A Phase 2 interventional study of SAGE-547 and Placebo in Essential Tremor, sponsored by Sage Therapeutics. Completed at 2 sites in United States. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-29.
Sponsored by Sage Therapeutics · Phase 2, Interventional, and Treatment
Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female participants with essential tremor in the upper limb.
Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who completed Stage 1 were invited to participate in Stage 2.
257 studies on the registry are indexed under Tremor; 59 are open to participants now.
This study's enrollment of 25 is close to the median of 25 across 184 interventional studies indexed under Tremor.
Browse Tremor studies →Sage Therapeutics is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Participants received a 12-hour intravenous (IV) infusion of SAGE 547, at ascending doses of 29, 58, and 86 micrograms per kilogram of body weight per hour (μg/kg/h), 4 hours each, on Day 1 of Stage 1 \[Treatment Period 1 (TP 1)\]. After a washout period of approximately 7 days, participants received a 12-hour IV infusion of SAGE-547 matching-placebo, on Day 10 of Stage 1 \[Treatment Period 2 (TP 2)\].
Drug: SAGE-547 · Drug: Placebo
Participants received a 12-hour IV infusion of SAGE-547 matching-placebo on Day 1 of Stage 1 (TP 1). After a washout period of approximately 7 days, participants received a 12-hour IV infusion of SAGE 547 at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 10 of Stage 1 (TP 2).
Drug: SAGE-547 · Drug: Placebo
Participants who completed Stage 1 were invited to receive a 10-hour IV infusion of SAGE 547, at ascending doses of 90 μg/kg/h for 1 hour, 120 μg/kg/h for 1 hour, and 150 μg/kg/h for 8 hours on Day 1 of Stage 2.
Drug: SAGE-547
Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition.
Time frame: Stage 1: Up to 30 days after last infusion (up to Day 40)
Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition.
Time frame: Stage 2: Up to 30 days after last infusion (up to Day 31)
Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit
The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. Only categories with data are reported.
Time frame: Stage 1: Pre-infusion on Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2)
Stage 2: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit
The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with SI and SB and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior.
Time frame: Stage 2 Day 1: Pre-infusion and 10 hours and 7-day follow-up post-infusion
Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Stage 1: Change From Baseline in Vital Signs Parameter - Temperature
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in Vital Signs Parameter - Temperature
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Stage 1: Change From Baseline in Serum Chemistry Parameter - Alanine Aminotransferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alanine aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Alanine Aminotransferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alanine aminotransferase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Aspartate Aminotransferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in aspartate aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Aspartate Aminotransferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for aspartate aminotransferase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in gamma glutamyl transferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for gamma glutamyl transferase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Sodium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in sodium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Sodium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for sodium levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Potassium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in potassium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Potassium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for potassium levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Calcium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in calcium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Calcium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for calcium levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Chloride Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in chloride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Chloride Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for chloride levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Bicarbonate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bicarbonate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Bicarbonate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bicarbonate levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Protein Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in protein levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Protein Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for protein levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Glucose Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in glucose levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Glucose Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for glucose levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Lactate Dehydrogenase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in lactate dehydrogenase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Lactate Dehydrogenase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for lactate dehydrogenase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Cholesterol Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in cholesterol levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Cholesterol Level
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for cholesterol levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Triglyceride Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in triglyceride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Triglyceride Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for triglyceride levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Albumin Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in albumin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Albumin Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for albumin levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Bilirubin Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bilirubin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Bilirubin Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bilirubin levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatinine Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Creatinine Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Blood Urea Nitrogen Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in blood urea nitrogen levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Blood Urea Nitrogen Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for blood urea nitrogen levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Alkaline Phosphatase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alkaline phosphatase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Alkaline Phosphatase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alkaline phosphatase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatine Kinase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine kinase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Creatine Kinase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine kinase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Phosphate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in phosphate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Phosphate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for phosphate levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Serum Chemistry Parameter - Urate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in urate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Serum Chemistry Parameter - Urate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for urate levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Hemoglobin Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Hemoglobin Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hemoglobin levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Hematocrit Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hematocrit levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Hematocrit Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hematocrit levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Platelet Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in platelet levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Platelet Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for platelet levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Erythrocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Erythrocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocyte levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Neutrophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in neutrophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Neutrophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for neutrophil levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Basophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in basophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Basophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for basophil levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Eosinophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in eosinophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Eosinophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for eosinophil levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Monocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in monocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Monocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for monocyte levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Lymphocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in lymphocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Lymphocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for lymphocyte levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Leukocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in leukocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Leukocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for leukocyte levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocytes mean corpuscular volume levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocytes mean corpuscular volume levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Hematology Parameter - Mean Cell Hemoglobin Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in mean cell hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Stage 2: Absolute Values of Hematology Parameter - Mean Cell Hemoglobin
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for mean cell hemoglobin levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8,12 hours during infusion
Stage 2: Change From Baseline in ECG Parameter - QT Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Stage 1: Change From Baseline in ECG Parameter - PR Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8,12 hours during infusion
Stage 2: Change From Baseline in ECG Parameter - PR Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Stage 1: Change From Baseline in ECG Parameter - QRS Duration
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion
Stage 2: Change From Baseline in ECG Parameter - QRS Duration
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Stage 1: Change From Baseline in ECG Parameter - QTcB Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion
Stage 2: Change From Baseline in ECG Parameter - QTcB Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Stage 1: Change From Baseline in ECG Parameter - QTcF Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion
Stage 2: Change From Baseline in ECG Parameter - QTcF Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Stage 1: Change From Baseline in ECG Parameter - Heart Rate
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion
Stage 2: Change From Baseline in ECG Parameter - Heart Rate
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Stage 1: Change From Baseline in Accelerometer Total Score Response
Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing-beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 1 Days 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in Accelerometer Total Score Response
Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Baseline and 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours
Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores
The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor \[right\], forward outstretched postural tremor \[left\], lateral wing-beating postural tremor \[right\], lateral wing-beating postural tremor \[left\], kinetic tremor \[right\], kinetic tremor \[left\], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 1 Days 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores
The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor \[right\], forward outstretched postural tremor \[left\], lateral wing-beating postural tremor \[right\], lateral wing-beating postural tremor \[left\], kinetic tremor \[right\], kinetic tremor \[left\], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor.
Time frame: Stage 2 Day 1: Baseline and at 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours
Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score
SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness.
Time frame: Stage 1 Day 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion
Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score
SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness.
Time frame: Stage 2 Day 1: Baseline and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours
Stage 1: Maximum Peak Plasma Concentration (Cmax) of SAGE-547
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Stage 2: Maximum Peak Plasma Concentration (Cmax) of SAGE-547
Time frame: Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Stage 1: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Stage 2: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547
Time frame: Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Stage 1: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Stage 2: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547
Time frame: Day 1: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Stage 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Stage 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547
Time frame: Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Stage 1: Clearance (CL) of SAGE-547
Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Stage 2: Clearance (CL) of SAGE-547
Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.
Time frame: Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Stage 1: Terminal Half-Life (t½) of SAGE-547
Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Stage 2: Terminal Half-Life (t½) of SAGE-547
Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
Time frame: Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Participants were enrolled at 2 investigative sites in the United States from 23 September 2014 to 14 August 2015.
| Milestone | Stage 1 (Double-blind): SAGE 547, Then Placebo | Stage 1 (Double-blind): Placebo, Then SAGE-547 | Stage 2 (Open Label): SAGE-547 |
|---|---|---|---|
| Started | 13 | 12 | 0 |
| Completed | 13 | 12 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Stage 1 (Double-blind): SAGE 547, Then Placebo | Stage 1 (Double-blind): Placebo, Then SAGE-547 | Stage 2 (Open Label): SAGE-547 |
|---|---|---|---|
| Started | 13 | 12 | 0 |
| Completed | 13 | 12 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Stage 1 (Double-blind): SAGE 547, Then Placebo | Stage 1 (Double-blind): Placebo, Then SAGE-547 | Stage 2 (Open Label): SAGE-547 |
|---|---|---|---|
| Started | 13 | 12 | 0 |
| Completed | 13 | 12 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Stage 1 (Double-blind): SAGE 547, Then Placebo | Stage 1 (Double-blind): Placebo, Then SAGE-547 | Stage 2 (Open Label): SAGE-547 |
|---|---|---|---|
| Started | 0 | 0 | 17 |
| Completed | 0 | 0 | 16 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 |
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition.
| percentage of participants | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| TEAEs | 12.0 | 20.0 |
| SAEs | 0 | 0 |
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition.
| percentage of participants | Stage 2: SAGE-547 |
|---|---|
| TEAEs | 47.1 |
| SAEs | 0 |
The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. Only categories with data are reported.
| percentage of participants | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Suicidal Ideation: Wish to be Dead: Pre-infusion | 0 | 4.0 |
| Suicidal Ideation: Non-specific Active Suicidal Thoughts: Pre-infusion | 4.0 | 0 |
| Suicidal Behavior: Actual Attempt: Pre-infusion | 4.0 | 4.0 |
The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with SI and SB and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior.
| percentage of participants | Stage 2: SAGE-547 |
|---|---|
| Stage 2: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | 0 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| millimeters of mercury (mmHg) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 121.6 ± 11.58 | 120.2 ± 15.47 |
| CFB at 4 Hours | -2.5 ± 10.84 | 4.0 ± 11.71 |
| CFB at 8 Hours | -3.9 ± 11.64 | 3.5 ± 10.24 |
| CFB at 12 Hours | -1.6 ± 10.44 | 7.6 ± 10.14 |
| CFB at 12-hour Follow-up | 5.6 ± 8.68 | 1.4 ± 11.85 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mmHg | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 125.3 ± 13.22 |
| CFB at 2 Hours | -12.1 ± 14.95 |
| CFB at 4 Hours | -7.6 ± 17.12 |
| CFB at 6 Hours | -7.9 ± 14.01 |
| CFB at 8 Hours | -6.8 ± 17.44 |
| CFB at 10 Hours | -2.9 ± 13.48 |
| CFB at 12 Hours | 4.0 ± 13.22 |
| CFB at 14 Hours | 3.1 ± 18.44 |
| CFB at 24 Hours | 4.3 ± 11.12 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mmHg | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 74.3 ± 8.90 | 75.0 ± 11.24 |
| CFB at 4 Hours | -2.3 ± 9.85 | -0.6 ± 6.10 |
| CFB at 8 Hours | -2.0 ± 6.79 | -0.7 ± 8.27 |
| CFB at 12 Hours | 0.4 ± 8.33 | 1.2 ± 9.69 |
| CFB at 12-hour Follow-up | 2.0 ± 8.17 | 0.8 ± 9.68 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mmHg | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 75.5 ± 7.63 |
| CFB at 2 Hours | -7.9 ± 8.59 |
| CFB at 4 Hours | -6.4 ± 10.20 |
| CFB at 6 Hours | -4.6 ± 9.70 |
| CFB at 8 Hours | -8.8 ± 10.17 |
| CFB at 10 Hours | -2.4 ± 9.52 |
| CFB at 12 Hours | 0.3 ± 8.80 |
| CFB at 14 Hours | -2.2 ± 9.03 |
| CFB at 24 Hours | -0.3 ± 8.99 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| beats per minute (bpm) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 66.0 ± 9.70 | 69.0 ± 12.99 |
| CFB at 4 Hours | -1.4 ± 7.52 | -2.1 ± 10.39 |
| CFB at 8 Hours | 2.0 ± 6.37 | 1.3 ± 14.85 |
| CFB at 12 Hours | 5.0 ± 8.67 | 2.1 ± 11.23 |
| CFB at 12-hour Follow-up | 2.9 ± 9.17 | -2.3 ± 8.96 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| bpm | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 69.5 ± 10.96 |
| CFB at 2 Hours | 0.7 ± 10.18 |
| CFB at 4 Hours | -3.3 ± 7.22 |
| CFB at 6 Hours | -3.3 ± 10.30 |
| CFB at 8 Hours | -1.5 ± 9.00 |
| CFB at 10 Hours | -1.5 ± 9.10 |
| CFB at 12 Hours | -2.1 ± 8.55 |
| CFB at 14 Hours | 3.9 ± 10.29 |
| CFB at 24 Hours | 2.6 ± 8.70 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mmHg | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 118.0 ± 17.27 | 119.1 ± 15.00 |
| CFB at 4 Hours | -2.2 ± 10.70 | 1.7 ± 12.48 |
| CFB at 8 Hours | -2.7 ± 13.23 | 1.0 ± 12.87 |
| CFB at 12 Hours | 2.0 ± 12.65 | 7.8 ± 11.48 |
| CFB at 12-hour Follow-up | 5.0 ± 15.82 | 1.7 ± 10.76 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mmHg | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 120.1 ± 13.05 |
| CFB at 2 Hours | -5.5 ± 15.98 |
| CFB at 4 Hours | -5.9 ± 13.87 |
| CFB at 6 Hours | -1.0 ± 16.84 |
| CFB at 8 Hours | -2.9 ± 14.22 |
| CFB at 10 Hours | -0.9 ± 16.49 |
| CFB at 12 Hours | 10.2 ± 17.28 |
| CFB at 14 Hours | 11.1 ± 18.98 |
| CFB at 24 Hours | 2.9 ± 9.30 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mmHg | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 76.2 ± 10.20 | 78.9 ± 11.84 |
| CFB at 4 Hours | -1.2 ± 8.86 | -3.1 ± 6.81 |
| CFB at 8 Hours | -2.1 ± 9.03 | -2.6 ± 7.34 |
| CFB at 12 Hours | 1.0 ± 9.53 | 0.6 ± 9.31 |
| CFB at 12-hour Follow-up | 2.7 ± 9.85 | 0.9 ± 6.65 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mmHg | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 78.9 ± 8.81 |
| CFB at 2 Hours | -5.6 ± 7.17 |
| CFB at 4 Hours | -4.5 ± 8.43 |
| CFB at 6 Hours | -4.1 ± 6.66 |
| CFB at 8 Hours | -4.7 ± 6.03 |
| CFB at 10 Hours | -4.3 ± 9.21 |
| CFB at 12 Hours | -1.3 ± 8.30 |
| CFB at 14 Hours | -0.6 ± 8.73 |
| CFB at 24 Hours | -1.5 ± 6.52 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| bpm | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 72.0 ± 9.66 | 75.6 ± 13.70 |
| CFB at 4 Hours | 0.0 ± 7.13 | -1.0 ± 9.17 |
| CFB at 8 Hours | 3.0 ± 7.55 | -0.0 ± 10.22 |
| CFB at 12 Hours | 5.4 ± 11.84 | 3.4 ± 8.23 |
| CFB at 12-hour Follow-up | 3.8 ± 8.15 | -1.5 ± 9.38 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| bpm | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 74.6 ± 10.12 |
| CFB at 2 Hours | 1.2 ± 9.25 |
| CFB at 4 Hours | 0.7 ± 7.69 |
| CFB at 6 Hours | -1.2 ± 7.06 |
| CFB at 8 Hours | 2.6 ± 11.09 |
| CFB at 10 Hours | 3.5 ± 8.53 |
| CFB at 12 Hours | -1.5 ± 6.26 |
| CFB at 14 Hours | 2.3 ± 10.02 |
| CFB at 24 Hours | 4.6 ± 11.17 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| degree Celsius | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 36.62 ± 0.14 | 36.58 ± 0.16 |
| CFB at 4 Hours | -0.03 ± 0.22 | 0.05 ± 0.25 |
| CFB at 8 Hours | -0.04 ± 0.16 | 0.06 ± 0.28 |
| CFB at 12 Hours | -0.02 ± 0.20 | 0.04 ± 0.23 |
| CFB at 12-hour Follow-up | -0.01 ± 0.22 | -0.00 ± 0.23 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| degree Celsius | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 36.64 ± 0.15 |
| CFB at 2 Hours | -0.01 ± 0.25 |
| CFB at 4 Hours | -0.06 ± 0.20 |
| CFB at 6 Hours | 0.01 ± 0.18 |
| CFB at 8 Hours | -0.02 ± 0.23 |
| CFB at 10 Hours | 0.02 ± 0.20 |
| CFB at 12 Hours | -0.01 ± 0.40 |
| CFB at 14 Hours | 0.02 ± 0.21 |
| CFB at 24 Hours | -0.01 ± 0.29 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| breaths per minute (breaths/min) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 16.0 ± 1.53 | 16.3 ± 1.46 |
| CFB at 4 Hours | 0.4 ± 2.55 | -0.2 ± 1.52 |
| CFB at 8 Hours | 0.7 ± 2.43 | 0.3 ± 2.30 |
| CFB at 12 Hours | 1.0 ± 2.30 | 0.4 ± 2.04 |
| CFB at 12-hour Follow-up | 0.4 ± 1.70 | 0.2 ± 1.31 |
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| breaths/min | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 16.9 ± 1.75 |
| CFB at 2 Hours | -0.5 ± 1.81 |
| CFB at 4 Hours | -0.4 ± 2.22 |
| CFB at 6 Hours | -0.9 ± 2.31 |
| CFB at 8 Hours | -0.4 ± 1.82 |
| CFB at 10 Hours | 0.3 ± 1.24 |
| CFB at 12 Hours | 0.5 ± 2.13 |
| CFB at 14 Hours | 0.1 ± 2.33 |
| CFB at 24 Hours | -0.5 ± 2.00 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alanine aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| units per liter (u/L) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 22.0 ± 12.15 | 23.3 ± 14.67 |
| CFB at 12-hour Follow-up | -1.4 ± 4.05 | -2.7 ± 5.69 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alanine aminotransferase levels are reported in this outcome measure.
| u/L | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 23.1 ± 11.81 |
| Any Day in 7-day Follow-up | 23.6 ± 13.06 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in aspartate aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| u/L | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 19.2 ± 6.31 | 19.0 ± 5.81 |
| CFB at 12-hour Follow-up | -0.7 ± 3.92 | -0.0 ± 4.32 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for aspartate aminotransferase levels are reported in this outcome measure.
| u/L | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 15.8 ± 4.82 |
| Any Day in 7-day Follow-up | 15.6 ± 5.66 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in gamma glutamyl transferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| u/L | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 27.0 ± 24.32 | 25.2 ± 21.40 |
| CFB at 12-hour Follow-up | 0.0 ± 4.16 | 1.2 ± 2.94 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for gamma glutamyl transferase levels are reported in this outcome measure.
| u/L | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 26.8 ± 21.72 |
| Any Day in 7-day Follow-up | 28.3 ± 19.65 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in sodium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| millimoles per liter (mmol/L) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 140.4 ± 2.38 | 140.2 ± 2.35 |
| CFB at 12-hour Follow-up | -0.2 ± 2.19 | -0.6 ± 3.28 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for sodium levels are reported in this outcome measure.
| mmol/L | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 139.4 ± 2.18 |
| Any Day in 7-day Follow-up | 139.4 ± 1.91 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in potassium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mmol/L | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 4.18 ± 0.273 | 4.17 ± 0.301 |
| CFB at 12-hour Follow-up | -0.00 ± 0.301 | 0.10 ± 0.335 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for potassium levels are reported in this outcome measure.
| mmol/L | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 4.36 ± 0.232 |
| Any Day in 7-day Follow-up | 4.42 ± 0.268 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in calcium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| milligrams per deciliter (mg/dL) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 9.07 ± 0.366 | 9.08 ± 0.376 |
| CFB at 12-hour Follow-up | -0.11 ± 0.492 | -0.12 ± 0.393 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for calcium levels are reported in this outcome measure.
| mg/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 9.19 ± 0.302 |
| Any Day in 7-day Follow-up | 9.12 ± 0.268 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in chloride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mmol/L | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 106.4 ± 3.34 | 105.8 ± 3.00 |
| CFB at 12-hour Follow-up | -0.2 ± 2.54 | -0.2 ± 2.00 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for chloride levels are reported in this outcome measure.
| mmol/L | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 103.8 ± 2.79 |
| Any Day in 7-day Follow-up | 104.2 ± 2.54 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bicarbonate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mmol/L | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 25.6 ± 3.47 | 25.6 ± 2.87 |
| CFB at 12-hour Follow-up | -0.4 ± 2.71 | -0.7 ± 2.95 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bicarbonate levels are reported in this outcome measure.
| mmol/L | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 26.6 ± 3.91 |
| Any Day in 7-day Follow-up | 26.3 ± 3.60 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in protein levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| grams per deciliter (g/dL) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 6.70 ± 0.452 | 6.66 ± 0.390 |
| CFB at 12-hour Follow-up | -0.08 ± 0.456 | 0.05 ± 0.366 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for protein levels are reported in this outcome measure.
| g/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 7.05 ± 0.403 |
| Any Day in 7-day Follow-up | 6.80 ± 0.417 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in glucose levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mg/dL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 108.0 ± 34.29 | 95.4 ± 17.21 |
| CFB at 12-hour Follow-up | 0.0 ± 38.89 | 19.6 ± 52.94 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for glucose levels are reported in this outcome measure.
| mg/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 108.1 ± 60.88 |
| Any Day in 7-day Follow-up | 112.8 ± 71.74 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in lactate dehydrogenase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| u/L | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 167.9 ± 32.75 | 153.1 ± 29.87 |
| CFB at 12-hour Follow-up | -16.6 ± 15.59 | -0.8 ± 17.57 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for lactate dehydrogenase levels are reported in this outcome measure.
| u/L | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 162.9 ± 39.06 |
| Any Day in 7-day Follow-up | 168.8 ± 40.97 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in cholesterol levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mg/dL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 183.0 ± 32.77 | 183.4 ± 24.63 |
| CFB at 12-hour Follow-up | 0.4 ± 14.01 | 2.1 ± 20.84 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for cholesterol levels are reported in this outcome measure.
| mg/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 194.6 ± 39.64 |
| Any Day in 7-day Follow-up | 179.7 ± 33.94 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in triglyceride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mg/dL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 166.1 ± 93.42 | 168.4 ± 77.72 |
| CFB at 12-hour Follow-up | -19.1 ± 67.47 | -25.1 ± 45.41 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for triglyceride levels are reported in this outcome measure.
| mg/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 162.4 ± 63.59 |
| Any Day in 7-day Follow-up | 163.4 ± 69.94 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in albumin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| g/dL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 3.94 ± 0.260 | 3.95 ± 0.315 |
| CFB at 12-hour Follow-up | -0.06 ± 0.314 | -0.01 ± 0.276 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for albumin levels are reported in this outcome measure.
| g/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 4.03 ± 0.331 |
| Any Day in 7-day Follow-up | 3.92 ± 0.299 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bilirubin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mg/dL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 0.44 ± 0.231 | 0.47 ± 0.313 |
| CFB at 12-hour Follow-up | 0.04 ± 0.144 | 0.09 ± 0.127 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bilirubin levels are reported in this outcome measure.
| mg/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 0.58 ± 0.354 |
| Any Day in 7-day Follow-up | 0.57 ± 0.463 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mg/dL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 0.940 ± 0.2480 | 0.951 ± 0.2912 |
| CFB at 12-hour Follow-up | -0.07 ± 0.104 | -0.09 ± 0.128 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine levels are reported in this outcome measure.
| mg/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 0.872 ± 0.2302 |
| Any Day in 7-day Follow-up | 0.912 ± 0.2234 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in blood urea nitrogen levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mg/dL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 18.1 ± 4.60 | 17.9 ± 5.73 |
| CFB at 12-hour Follow-up | -0.4 ± 4.36 | -0.3 ± 3.08 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for blood urea nitrogen levels are reported in this outcome measure.
| mg/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 17.3 ± 4.31 |
| Any Day in 7-day Follow-up | 16.6 ± 3.37 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alkaline phosphatase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| u/L | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 69.1 ± 13.97 | 67.1 ± 13.58 |
| CFB at 12-hour Follow-up | -2.4 ± 5.37 | -0.4 ± 6.83 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alkaline phosphatase levels are reported in this outcome measure.
| u/L | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 71.1 ± 13.99 |
| Any Day in 7-day Follow-up | 71.4 ± 14.33 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine kinase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| u/L | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 100.5 ± 71.25 | 124.0 ± 188.98 |
| CFB at 12-hour Follow-up | -20.6 ± 25.57 | -36.2 ± 90.71 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine kinase levels are reported in this outcome measure.
| u/L | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 83.9 ± 32.51 |
| Any Day in 7-day Follow-up | 85.9 ± 44.45 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in phosphate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mg/dL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 3.58 ± 0.468 | 3.52 ± 0.551 |
| CFB at 12-hour Follow-up | -0.16 ± 0.481 | -0.17 ± 0.581 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for phosphate levels are reported in this outcome measure.
| mg/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 3.36 ± 0.436 |
| Any Day in 7-day Follow-up | 3.23 ± 0.461 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in urate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| mg/dL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 4.53 ± 1.249 | 4.71 ± 1.366 |
| CFB at 12-hour Follow-up | 0.05 ± 0.532 | -0.04 ± 0.317 |
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for urate levels are reported in this outcome measure.
| mg/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 4.66 ± 1.169 |
| Any Day in 7-day Follow-up | 4.84 ± 1.183 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| g/dL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 13.56 ± 1.276 | 13.63 ± 1.179 |
| CFB at 12-hours Follow-up | 0.34 ± 0.733 | 0.28 ± 0.768 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hemoglobin levels are reported in this outcome measure.
| g/dL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 14.74 ± 1.419 |
| Any Day in 7-day Follow-up | 14.11 ± 1.684 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hematocrit levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| percentage of cells | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 40.66 ± 3.463 | 40.97 ± 3.453 |
| CFB at 12-hours Follow-up | 1.02 ± 2.013 | 0.67 ± 2.494 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hematocrit levels are reported in this outcome measure.
| percentage of cells | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 45.04 ± 4.230 |
| Any Day in 7-day Follow-up | 43.28 ± 5.128 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in platelet levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| 10^3 cells per microliter(10^3 cells/μL) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 212.5 ± 40.56 | 218.8 ± 48.31 |
| CFB at 12-hours Follow-up | -11.7 ± 45.02 | -7.1 ± 37.11 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for platelet levels are reported in this outcome measure.
| 10^3 cells/μL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 233.8 ± 48.03 |
| Any Day in 7-day Follow-up | 230.5 ± 45.93 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| 10^6 cells per microliter(10^6 cells/μL) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 4.437 ± 0.4032 | 4.474 ± 0.4119 |
| CFB at 12-hours Follow-up | 0.09 ± 0.223 | 0.07 ± 0.271 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocyte levels are reported in this outcome measure.
| 10^6 cells/μL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 4.925 ± 0.4173 |
| Any Day in 7-day Follow-up | 4.735 ± 0.5289 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in neutrophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| 10^3 cells/μL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 4.510 ± 1.2311 | 4.781 ± 1.6007 |
| CFB at 12-hours Follow-up | -0.49 ± 0.941 | -0.66 ± 1.053 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for neutrophil levels are reported in this outcome measure.
| 10^3 cells/μL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 4.049 ± 0.8958 |
| Any Day in 7-day Follow-up | 4.176 ± 0.8065 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in basophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| cells per microliter (cells/μL) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 25.4 ± 15.61 | 27.2 ± 20.45 |
| CFB at 12-hours Follow-up | 6.4 ± 17.06 | -8.3 ± 21.83 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for basophil levels are reported in this outcome measure.
| cells/μL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 35.3 ± 20.70 |
| Any Day in 7-day Follow-up | 45.3 ± 47.64 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in eosinophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| cells/μL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 158.8 ± 77.53 | 140.3 ± 109.72 |
| CFB at 12-hours Follow-up | 11.5 ± 45.21 | 42.5 ± 47.48 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for eosinophil levels are reported in this outcome measure.
| cells/μL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 87.2 ± 40.49 |
| Any Day in 7-day Follow-up | 99.8 ± 75.37 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in monocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| cells/μL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 480.5 ± 264.68 | 462.8 ± 240.92 |
| CFB at 12-hours Follow-up | -22.9 ± 176.01 | -40.3 ± 113.21 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for monocyte levels are reported in this outcome measure.
| cells/μL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 499.8 ± 190.38 |
| Any Day in 7-day Follow-up | 426.7 ± 133.11 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in lymphocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| cells/μL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 1641.7 ± 423.63 | 1590.1 ± 427.61 |
| CFB at 12-hours Follow-up | 176.5 ± 244.63 | 100.3 ± 310.99 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for lymphocyte levels are reported in this outcome measure.
| cells/μL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 2080.0 ± 908.52 |
| Any Day in 7-day Follow-up | 1871.8 ± 858.64 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in leukocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| 10^3 cells/μL | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 6.976 ± 1.9550 | 6.972 ± 2.1314 |
| CFB at 12-hours Follow-up | -0.12 ± 1.090 | -0.43 ± 0.927 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for leukocyte levels are reported in this outcome measure.
| 10^3 cells/μL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 6.928 ± 1.7603 |
| Any Day in 7-day Follow-up | 6.688 ± 1.5791 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocytes mean corpuscular volume levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| femtoliter (fL) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 91.71 ± 3.774 | 91.72 ± 3.780 |
| CFB at 12-hours Follow-up | 0.30 ± 0.810 | -0.03 ± 0.833 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocytes mean corpuscular volume levels are reported in this outcome measure.
| fL | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 91.59 ± 5.264 |
| Any Day in 7-day Follow-up | 91.43 ± 4.718 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in mean cell hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| picograms (pg) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 30.58 ± 1.540 | 30.90 ± 1.760 |
| CFB at 12-hours Follow-up | 0.18 ± 0.468 | -0.30 ± 0.792 |
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for mean cell hemoglobin levels are reported in this outcome measure.
| pg | Stage 2: SAGE-547 |
|---|---|
| Any Day in Screening Period (Day -7 up to Day -1) | 29.93 ± 2.890 |
| Any Day in 7-day Follow-up | 29.97 ± 2.809 |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| milliseconds (msec) | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 392.0 (362 to 493) | 394.0 (359 to 462) |
| CFB at 4 Hours | 3.0 (-88 to 28) | -2.0 (-31 to 26) |
| CFB at 8 Hours | -8.0 (-92 to 18) | -10.0 (-64 to 38) |
| CFB at 12 Hours | -12.0 (-90 to 24) | -14.0 (-48 to 32) |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| msec | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 376.0 (368 to 422) |
| CFB at 10 Hours | -1.0 (-33 to 28) |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| msec | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 168.0 (108 to 214) | 170.0 (116 to 262) |
| CFB at 4 Hours | 0.0 (-168 to 46) | -4.0 (-46 to 28) |
| CFB at 8 Hours | -3.0 (-18 to 54) | -2.0 (-30 to 18) |
| CFB at 12 Hours | -4.0 (-158 to 74) | -6.0 (-52 to 39) |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| msec | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 144.0 (136 to 174) |
| CFB at 10 Hours | 2.5 (-6 to 43) |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| msec | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 86.0 (72 to 236) | 85.0 (72 to 122) |
| CFB at 4 Hours | 0.0 (-162 to 15) | 0.0 (-10 to 6) |
| CFB at 8 Hours | 0.0 (-166 to 9) | 0.0 (-8 to 13) |
| CFB at 12 Hours | 0.0 (-162 to 22) | 0.0 (-13 to 15) |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| msec | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 90.0 (74 to 122) |
| CFB at 10 Hours | 0.0 (-6 to 15) |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| msec | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 412.0 (380 to 524) | 413.0 (383 to 455) |
| CFB at 4 Hours | -1.0 (-111 to 18) | 1.0 (-27 to 20) |
| CFB at 8 Hours | 5.0 (-115 to 28) | 0.0 (-25 to 20) |
| CFB at 12 Hours | 4.0 (-108 to 78) | -1.0 (-18 to 24) |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| msec | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 421.0 (391 to 446) |
| CFB at 10 Hours | 1.5 (-22 to 25) |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| msec | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 404.0 (380 to 502) | 404.0 (389 to 451) |
| CFB at 4 Hours | 2.0 (-103 to 20) | 0.0 (-24 to 18) |
| CFB at 8 Hours | 1.0 (-108 to 17) | -3.0 (-17 to 20) |
| CFB at 12 Hours | 1.0 (-102 to 59) | -7.0 (-17 to 23) |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| msec | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 406.0 (386 to 438) |
| CFB at 10 Hours | 2.5 (-15 to 26) |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| bpm | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 65.0 ± 9.70 | 65.0 ± 9.09 |
| CFB at 4 Hours | -1.9 ± 6.36 | 0.2 ± 4.33 |
| CFB at 8 Hours | 3.3 ± 6.46 | 3.0 ± 9.05 |
| CFB at 12 Hours | 5.5 ± 7.35 | 4.6 ± 7.34 |
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
| bpm | Stage 2: SAGE-547 |
|---|---|
| Pre-infusion | 72.0 ± 8.27 |
| CFB at 10 Hours | -0.4 ± 5.97 |
Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing-beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage.
| score on a scale | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 7.13 ± 3.902 | 7.41 ± 4.137 |
| CFB at 2 Hours | -0.96 ± 1.373 | -1.05 ± 1.563 |
| CFB at 4 Hours | -0.83 ± 1.876 | -0.74 ± 1.833 |
| CFB at 6 Hours | -1.25 ± 1.943 | -0.75 ± 1.186 |
| CFB at 8 Hours | -0.93 ± 1.903 | -1.03 ± 1.447 |
| CFB at 10 Hours | -1.24 ± 1.814 | -0.85 ± 1.713 |
| CFB at 12 Hours | -1.39 ± 1.436 | -0.91 ± 1.284 |
| CFB at 12-hour Follow-up | 0.05 ± 1.498 | -0.21 ± 1.927 |
Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage.
| score on a scale | Stage 2: SAGE-547 |
|---|---|
| Baseline | 6.96 ± 4.901 |
| CFB at 2 Hours | -1.37 ± 2.202 |
| CFB at 3 Hours | -1.25 ± 1.890 |
| CFB at 4 Hours | -1.57 ± 2.186 |
| CFB at 6 Hours | -1.44 ± 2.553 |
| CFB at 8 Hours | -2.06 ± 2.942 |
| CFB at 10 Hours | -1.16 ± 1.809 |
| CFB at 12 Hours | -0.89 ± 1.845 |
| CFB at 14 Hours | -0.35 ± 1.780 |
| CFB at 24 Hours | 0.18 ± 2.033 |
The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor \[right\], forward outstretched postural tremor \[left\], lateral wing-beating postural tremor \[right\], lateral wing-beating postural tremor \[left\], kinetic tremor \[right\], kinetic tremor \[left\], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor. Baseline is defined as the pre-infusion value in each period/stage.
| score on a scale | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 9.48 ± 3.917 | 9.72 ± 3.199 |
| CFB at 2 Hours | -2.10 ± 2.309 | -2.10 ± 1.860 |
| CFB at 4 Hours | -2.06 ± 2.205 | -2.72 ± 2.107 |
| CFB at 6 Hours | -2.94 ± 2.007 | -1.84 ± 1.553 |
| CFB at 8 Hours | -2.94 ± 2.682 | -2.74 ± 1.943 |
| CFB at 10 Hours | -2.94 ± 2.505 | -2.60 ± 1.898 |
| CFB at 12 Hours | -3.48 ± 2.632 | -2.46 ± 2.031 |
| CFB at 12-hour Follow-up | -1.38 ± 1.943 | -1.70 ± 1.507 |
The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor \[right\], forward outstretched postural tremor \[left\], lateral wing-beating postural tremor \[right\], lateral wing-beating postural tremor \[left\], kinetic tremor \[right\], kinetic tremor \[left\], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor.
| score on a scale | Stage 2: SAGE-547 |
|---|---|
| Baseline | 9.24 ± 1.977 |
| CFB at 2 Hours | -1.66 ± 2.173 |
| CFB at 3 Hours | -2.44 ± 2.542 |
| CFB at 4 Hours | -3.25 ± 2.550 |
| CFB at 6 Hours | -2.66 ± 2.612 |
| CFB at 8 Hours | -3.16 ± 2.809 |
| CFB at 10 Hours | -2.19 ± 1.642 |
| CFB at 12 Hours | -1.25 ± 1.602 |
| CFB at 14 Hours | -0.66 ± 1.091 |
| CFB at 24 Hours | -0.84 ± 1.850 |
SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness.
| score on a scale | Stage 1: SAGE-547 | Stage 1: Placebo |
|---|---|---|
| Pre-infusion | 1.6 ± 0.77 | 1.6 ± 0.76 |
| CFB at 2 Hours | 0.3 ± 1.37 | 0.0 ± 0.41 |
| CFB at 4 Hours | 0.3 ± 1.40 | 0.1 ± 0.53 |
| CFB at 6 Hours | 0.7 ± 1.09 | 0.1 ± 0.83 |
| CFB at 8 Hours | 0.1 ± 1.08 | 0.0 ± 0.82 |
| CFB at 10 Hours | 0.3 ± 1.40 | 0.2 ± 0.93 |
| CFB at 12 Hours | 0.2 ± 0.87 | -0.0 ± 0.89 |
| CFB at 12-hour Follow-up | -0.1 ± 0.54 | -0.2 ± 0.75 |
SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness.
| score on a scale | Stage 2: SAGE-547 |
|---|---|
| Baseline | 1.5 ± 0.62 |
| CFB at 1 Hour | 0.4 ± 1.12 |
| CFB at 2 Hours | 1.4 ± 1.09 |
| CFB at 3 Hours | 2.5 ± 2.10 |
| CFB at 4 Hours | 3.1 ± 1.81 |
| CFB at 5 Hours | 3.3 ± 2.02 |
| CFB at 6 Hours | 3.3 ± 1.91 |
| CFB at 7 Hours | 2.6 ± 1.79 |
| CFB at 8 Hours | 2.4 ± 1.86 |
| CFB at 9 Hours | 2.3 ± 1.91 |
| CFB at 10 Hours | 2.0 ± 1.97 |
| CFB at 11 Hours | 0.1 ± 0.85 |
| CFB at 12 Hours | -0.3 ± 0.86 |
| CFB at 14 Hours | 0.3 ± 1.44 |
| CFB at 24 Hours | -0.3 ± 0.86 |
| nanograms per milliliter (ng/mL) | Stage 1: SAGE-547 |
|---|---|
| Stage 1: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | 84.3 ± 28.2 |
| ng/mL | Stage 2: SAGE-547 |
|---|---|
| Stage 2: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | 152 ± 36 |
| hours | Stage 1: SAGE-547 |
|---|---|
| Stage 1: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | 10 (1 to 12.483) |
| hours | Stage 2: SAGE-547 |
|---|---|
| Stage 2: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | 6 (2.967 to 9.05) |
| nanograms*hours per milliliter (ng*h/mL) | Stage 1: SAGE-547 |
|---|---|
| Stage 1: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 | 654 ± 251 |
| ng*h/mL | Stage 2: SAGE-547 |
|---|---|
| Stage 2: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 | 1310 ± 300 |
| ng*h/mL | Stage 1: SAGE-547 |
|---|---|
| Stage 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 | 716 ± 286 |
| ng*h/mL | Stage 2: SAGE-547 |
|---|---|
| Stage 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 | 1380 ± 300 |
Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.
| liters per hour per kilogram (L/h/kg) | Stage 1: SAGE-547 |
|---|---|
| Stage 1: Clearance (CL) of SAGE-547 | 1.09 ± 0.41 |
Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.
| L/h/kg | Stage 2: SAGE-547 |
|---|---|
| Stage 2: Clearance (CL) of SAGE-547 | 1.07 ± 0.28 |
Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
| hours | Stage 1: SAGE-547 |
|---|---|
| Stage 1: Terminal Half-Life (t½) of SAGE-547 | 5.6 (1.8 to 12.8) |
Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
| hours | Stage 2: SAGE-547 |
|---|---|
| Stage 2: Terminal Half-Life (t½) of SAGE-547 | 7.6 (4.8 to 9.5) |
Collected over Stage 1: Up to 30 days after last infusion (up to Day 40); Stage 2: Up to 30 days after last infusion (up to Day 31). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage 1: SAGE-547 | 0/25 (0%) | 0/25 (0%) | 1/25 (4%) |
| Stage 1: Placebo | 0/25 (0%) | 0/25 (0%) | 3/25 (12%) |
| Stage 2: SAGE-547 | 0/17 (0%) | 0/17 (0%) | 8/17 (47.1%) |
| Event | Stage 1: SAGE-547 | Stage 1: Placebo | Stage 2: SAGE-547 |
|---|---|---|---|
| FatigueGeneral disorders | 1/25 | 0/25 | 4/17 |
| DizzinessNervous system disorders | 0/25 | 2/25 | 3/17 |
| HyperbilirubinaemiaHepatobiliary disorders | 0/25 | 0/25 | 1/17 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 0/25 | 0/25 | 1/17 |
| HeadacheNervous system disorders | 0/25 | 1/25 | 1/17 |
| SedationNervous system disorders | 0/25 | 0/25 | 1/17 |
| HypotensionVascular disorders | 0/25 | 0/25 | 1/17 |
Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Age, Continuous(years) | Stage 1 (Double-blind): SAGE-547 and Placebo |
|---|---|
| Mean | 64.2 ± 5.7 |
| Sex: Female, Male(Participants) | Stage 1 (Double-blind): SAGE-547 and Placebo |
|---|---|
| Female | 15 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Stage 1 (Double-blind): SAGE-547 and Placebo |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Stage 1 (Double-blind): SAGE-547 and Placebo |
|---|---|
| Black or African American | 1 |
| White | 22 |
| Other | 2 |
Plan to share: No — Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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