A Phase 1 interventional study of CVL-354 and Placebo in Healthy Participants, sponsored by Cerevel Therapeutics, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by Cerevel Therapeutics, LLC (part of AbbVie) · Phase 1, Interventional, and Treatment
This is a 2-part, double-blind, randomized, placebo-controlled, first-in-human trial evaluating a single ascending dose (4-way crossover, Part A) and multiple ascending doses (Part B) of CVL-354.
Cerevel Therapeutics, LLC is the lead sponsor of 22 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
First submitted before Cerevel Therapeutics, LLC became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination or booster as follows:
Either of the following:
Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 1.5 milligrams (mg) on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
Drug: CVL-354 · Drug: Placebo
Participants were randomized to sequence 2 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
Drug: CVL-354 · Drug: Placebo
Participants were randomized to sequence 3 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by placebo on Day 1 of Period 3 \& followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
Drug: CVL-354 · Drug: Placebo
Participants were randomized to sequence 4 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 \& followed by placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
Drug: CVL-354 · Drug: Placebo
Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
Drug: CVL-354 · Drug: Placebo
Participants were randomized to sequence 2 to receive CVL-354 45 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
Drug: CVL-354 · Drug: Placebo
Participants were randomized to sequence 3 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 on 90 mg Day 1 of Period 2, followed by placebo on Day 1 of Period 3 \& followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
Drug: CVL-354 · Drug: Placebo
Participants were randomized to sequence 4 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 \& placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days.
Drug: CVL-354 · Drug: Placebo
Participants first received a single oral dose of CVL-354 50 mg, under fed state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fasted state on Day 1 of Period 2, with a washout period of 2 days between both periods.
Drug: CVL-354
Participants first received a single oral dose of CVL-354 50 mg, under fasted state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fed state on Day 1 of Period 2, with a washout period of 2 days between both periods
Drug: CVL-354
Participants received oral dose of CVL-354 10 mg or Placebo, once daily (QD) from Day 1 up to Day 14 in Cohort 1.
Drug: CVL-354 · Drug: Placebo
Participants received oral dose of CVL-354 25 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 2.
Drug: Placebo · Drug: CVL-354
Participants received oral dose of CVL-354 50 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 3.
Drug: Placebo · Drug: CVL-354
Participants received oral dose of CVL-354 80 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 4.
Drug: Placebo · Drug: CVL-354
Participants received oral dose of CVL-354 85 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 5.
Drug: Placebo · Drug: CVL-354
Part A: Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A serious adverse event (SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs.
Time frame: From the first dose of study drug up to end of follow-up period (Up to 72 days)
Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 72 days)
Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 72 days)
Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 72 days)
Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations
The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 72 days)
Part A: Cohorts 1 and 2: Number of Participants With Changes in Suicidal Ideation or Suicidal Behavior Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)
The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior. Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category.
Time frame: From the first dose of study drug up to end of treatment (Up to 72 days)
Part A: Cohort 3: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A SAE was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs.
Time frame: From the first dose of study drug up to end of follow up period (Up to 22 days)
Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in ECG Parameters
ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 22 days)
Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 22 days)
Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 22 days)
Part A: Cohort 3: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations
The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 22 days)
Part A: Cohort 3: Number of Participants With Changes in C-SSRS
The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior. Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category.
Time frame: From the first dose of study drug up to end of treatment (Up to 22 days)
Part B: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A SAE was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs.
Time frame: From the first dose of study drug up to end of follow up period (Up to 31 days)
Part B: Number of Participants With Clinically Significant Changes in ECG Parameters
ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 31 days)
Part B: Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 31 days)
Part B: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 31 days)
Part B: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations
The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported.
Time frame: From the first dose of study drug up to end of treatment (Up to 31 days)
Part B: Number of Participants With Changes in C-SSRS
The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category.
Time frame: From the first dose of study drug up to end of treatment (Up to 31 days)
73 participants took part in the study at 1 investigative site in the United States of America from 18 October 2021 to 23 January 2023.
| Milestone | Part A: Cohort 1: Sequence 1 | Part A: Cohort 1: Sequence 2 | Part A: Cohort 1: Sequence 3 | Part A: Cohort 1: Sequence 4 | Part A: Cohort 2: Sequence 1 | Part A: Cohort 2: Sequence 2 | Part A: Cohort 2: Sequence 3 | Part A: Cohort 2: Sequence 4 | Part A: Cohort 3: Fed/Fasted Sequence | Part A: Cohort 3: Fasted/Fed Sequence | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 2 | 4 | 2 | 2 | 3 | 2 | 3 | 2 | 4 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 1 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 1 | 2 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Investigator's discretion | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal of consent | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part A: Cohort 1: Sequence 1 | Part A: Cohort 1: Sequence 2 | Part A: Cohort 1: Sequence 3 | Part A: Cohort 1: Sequence 4 | Part A: Cohort 2: Sequence 1 | Part A: Cohort 2: Sequence 2 | Part A: Cohort 2: Sequence 3 | Part A: Cohort 2: Sequence 4 | Part A: Cohort 3: Fed/Fasted Sequence | Part A: Cohort 3: Fasted/Fed Sequence | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 8 | 6 | 7 | 8 | 8 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 8 | 5 | 6 | 7 | 7 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
| Withdrew: Withdrawal of consent | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Disciplinary reason | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A serious adverse event (SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs.
| Participants | Part A: Cohort 1 and 2: Pooled Placebo | Part A: Cohort 1: CVL-354 0.5 mg | Part A: Cohort 1: CVL-354 1.5 mg | Part A: Cohort 1: CVL-354 5 mg | Part A: Cohort 1: CVL-354 15 mg | Part A: Cohort 2: CVL-354 45 mg | Part A: Cohort 2: CVL-354 90 mg | Part A: Cohort 2: CVL-354 150 mg | Part A: Cohort 2: CVL-354 200 mg |
|---|---|---|---|---|---|---|---|---|---|
| Part A: Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 2 |
ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported.
| Participants | Part A: Cohort 1 and 2: Pooled Placebo | Part A: Cohort 1: CVL-354 0.5 mg | Part A: Cohort 1: CVL-354 1.5 mg | Part A: Cohort 1: CVL-354 5 mg | Part A: Cohort 1: CVL-354 15 mg | Part A: Cohort 2: CVL-354 45 mg | Part A: Cohort 2: CVL-354 90 mg | Part A: Cohort 2: CVL-354 150 mg | Part A: Cohort 2: CVL-354 200 mg |
|---|---|---|---|---|---|---|---|---|---|
| Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported.
| Participants | Part A: Cohort 1 and 2: Pooled Placebo | Part A: Cohort 1: CVL-354 0.5 mg | Part A: Cohort 1: CVL-354 1.5 mg | Part A: Cohort 1: CVL-354 5 mg | Part A: Cohort 1: CVL-354 15 mg | Part A: Cohort 2: CVL-354 45 mg | Part A: Cohort 2: CVL-354 90 mg | Part A: Cohort 2: CVL-354 150 mg | Part A: Cohort 2: CVL-354 200 mg |
|---|---|---|---|---|---|---|---|---|---|
| Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Sign Measurements | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported.
| Participants | Part A: Cohort 1 and 2: Pooled Placebo | Part A: Cohort 1: CVL-354 0.5 mg | Part A: Cohort 1: CVL-354 1.5 mg | Part A: Cohort 1: CVL-354 5 mg | Part A: Cohort 1: CVL-354 15 mg | Part A: Cohort 2: CVL-354 45 mg | Part A: Cohort 2: CVL-354 90 mg | Part A: Cohort 2: CVL-354 150 mg | Part A: Cohort 2: CVL-354 200 mg |
|---|---|---|---|---|---|---|---|---|---|
| Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported.
| Participants | Part A: Cohort 1 and 2: Pooled Placebo | Part A: Cohort 1: CVL-354 0.5 mg | Part A: Cohort 1: CVL-354 1.5 mg | Part A: Cohort 1: CVL-354 5 mg | Part A: Cohort 1: CVL-354 15 mg | Part A: Cohort 2: CVL-354 45 mg | Part A: Cohort 2: CVL-354 90 mg | Part A: Cohort 2: CVL-354 150 mg | Part A: Cohort 2: CVL-354 200 mg |
|---|---|---|---|---|---|---|---|---|---|
| Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior. Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category.
| Participants | Part A: Cohort 1 and 2: Pooled Placebo | Part A: Cohort 1: CVL-354 0.5 mg | Part A: Cohort 1: CVL-354 1.5 mg | Part A: Cohort 1: CVL-354 5 mg | Part A: Cohort 1: CVL-354 15 mg | Part A: Cohort 2: CVL-354 45 mg | Part A: Cohort 2: CVL-354 90 mg | Part A: Cohort 2: CVL-354 150 mg | Part A: Cohort 2: CVL-354 200 mg |
|---|---|---|---|---|---|---|---|---|---|
| Part A: Cohorts 1 and 2: Number of Participants With Changes in Suicidal Ideation or Suicidal Behavior Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A SAE was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs.
| Participants | Part A: Cohort 3: Fed State | Part A: Cohort 3: Fasted State |
|---|---|---|
| Part A: Cohort 3: Number of Participants With TEAEs | 0 | 2 |
ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported.
| Participants | Part A: Cohort 3: Fed State | Part A: Cohort 3: Fasted State |
|---|---|---|
| Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in ECG Parameters | 0 | 0 |
Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported.
| Participants | Part A: Cohort 3: Fed State | Part A: Cohort 3: Fasted State |
|---|---|---|
| Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Vital Sign Measurements | 0 | 0 |
Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported.
| Participants | Part A: Cohort 3: Fed State | Part A: Cohort 3: Fasted State |
|---|---|---|
| Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | 0 | 0 |
The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported.
| Participants | Part A: Cohort 3: Fed State | Part A: Cohort 3: Fasted State |
|---|---|---|
| Part A: Cohort 3: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations | 0 | 0 |
The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior. Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category.
| Participants | Part A: Cohort 3: Fed State | Part A: Cohort 3: Fasted Stated |
|---|---|---|
| Part A: Cohort 3: Number of Participants With Changes in C-SSRS | 0 | 0 |
An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A SAE was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs.
| Participants | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg |
|---|---|---|---|---|---|---|
| Part B: Number of Participants With TEAEs | 2 | 0 | 1 | 2 | 2 | 3 |
ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported.
| Participants | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg |
|---|---|---|---|---|---|---|
| Part B: Number of Participants With Clinically Significant Changes in ECG Parameters | 0 | 0 | 0 | 0 | 0 | 0 |
Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported.
| Participants | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 2: CVL-354 50 mg | Part B: Cohort 3: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg |
|---|---|---|---|---|---|---|
| Part B: Number of Participants With Clinically Significant Changes in Vital Sign Measurements | 0 | 0 | 0 | 0 | 0 | 0 |
Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported.
| Participants | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg |
|---|---|---|---|---|---|---|
| Part B: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | 0 | 0 | 0 | 0 | 0 | 0 |
The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported.
| Participants | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg |
|---|---|---|---|---|---|---|
| Part B: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations | 0 | 0 | 0 | 0 | 0 | 0 |
The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category.
| Participants | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg |
|---|---|---|---|---|---|---|
| Part B: Number of Participants With Changes in C-SSRS | 0 | 0 | 0 | 0 | 0 | 0 |
Collected over Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: Cohorts 1 and 2: Pooled Placebo | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Part A: Cohort 1: CVL-354 0.5 mg | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Part A: Cohort 1: CVL-354 1.5 mg | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Part A: Cohort 1: CVL-354 5 mg | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Part A: Cohort 1: CVL-354 15 mg | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Part A: Cohort 2: CVL-354 45 mg | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) |
| Part A: Cohort 2: CVL-354 90 mg | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Part A: Cohort 2: CVL-354 150 mg | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Part A: Cohort 2: CVL-354 200 mg | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Part A: Cohort 3: Fed State | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Part A: Cohort 3: Fasted State | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Part B: Pooled Placebo | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| Part B: Cohort 1: CVL-354 10 mg | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Part B: Cohort 2: CVL-354 25 mg | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Part B: Cohort 3: CVL-354 50 mg | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Part B: Cohort 4: CVL-354 80 mg | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| Part B: Cohort 5: CVL-354 85 mg | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Event | Part A: Cohorts 1 and 2: Pooled Placebo | Part A: Cohort 1: CVL-354 0.5 mg | Part A: Cohort 1: CVL-354 1.5 mg | Part A: Cohort 1: CVL-354 5 mg | Part A: Cohort 1: CVL-354 15 mg | Part A: Cohort 2: CVL-354 45 mg | Part A: Cohort 2: CVL-354 90 mg | Part A: Cohort 2: CVL-354 150 mg | Part A: Cohort 2: CVL-354 200 mg | Part A: Cohort 3: Fed State | Part A: Cohort 3: Fasted State | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/16 | 0/6 | 0/6 | 0/6 | 0/5 | 1/5 | 0/4 | 0/6 | 0/6 | 0/7 | 0/7 | 0/9 | 0/8 | 0/6 | 1/7 | 0/8 | 3/8 |
| VomitingGastrointestinal disorders | 0/16 | 0/6 | 0/6 | 0/6 | 0/5 | 0/5 | 0/4 | 1/6 | 2/6 | 0/7 | 0/7 | 0/9 | 0/8 | 0/6 | 0/7 | 0/8 | 0/8 |
| NauseaGastrointestinal disorders | 0/16 | 0/6 | 0/6 | 0/6 | 0/5 | 0/5 | 0/4 | 1/6 | 1/6 | 0/7 | 0/7 | 0/9 | 0/8 | 0/6 | 0/7 | 0/8 | 1/8 |
| DizzinessNervous system disorders | 0/16 | 0/6 | 0/6 | 0/6 | 0/5 | 0/5 | 0/4 | 0/6 | 1/6 | 0/7 | 0/7 | 0/9 | 0/8 | 0/6 | 1/7 | 0/8 | 0/8 |
| HeadacheNervous system disorders | 0/16 | 0/6 | 0/6 | 0/6 | 0/5 | 0/5 | 0/4 | 0/6 | 1/6 | 0/7 | 0/7 | 0/9 | 0/8 | 0/6 | 1/7 | 0/8 | 0/8 |
| Coronavirus disease 2019 (COVID-19)Infections and infestations | 0/16 | 0/6 | 0/6 | 1/6 | 0/5 | 0/5 | 0/4 | 0/6 | 0/6 | 0/7 | 0/7 | 1/9 | 0/8 | 0/6 | 0/7 | 1/8 | 0/8 |
| Product taste abnormalProduct Issues | 0/16 | 0/6 | 0/6 | 0/6 | 0/5 | 0/5 | 0/4 | 0/6 | 1/6 | 0/7 | 0/7 | 0/9 | 0/8 | 0/6 | 0/7 | 0/8 | 0/8 |
| Alanine aminotransferase increasedInvestigations | 0/16 | 0/6 | 0/6 | 0/6 | 0/5 | 0/5 | 0/4 | 0/6 | 0/6 | 0/7 | 0/7 | 0/9 | 0/8 | 1/6 | 0/7 | 0/8 | 0/8 |
| Feeling abnormalGeneral disorders | 0/16 | 0/6 | 0/6 | 0/6 | 0/5 | 0/5 | 0/4 | 0/6 | 0/6 | 0/7 | 1/7 | 0/9 | 0/8 | 0/6 | 0/7 | 0/8 | 0/8 |
| Laryngitis viralInfections and infestations | 0/16 | 0/6 | 0/6 | 0/6 | 0/5 | 0/5 | 0/4 | 0/6 | 0/6 | 0/7 | 1/7 | 0/9 | 0/8 | 0/6 | 0/7 | 0/8 | 0/8 |
Randomized Population included all participants who were randomized to investigational medicinal product (IMP).
| Age, Categorical(Participants) | Part A: Cohort 1: Sequence 1 | Part A: Cohort 1: Sequence 2 | Part A: Cohort 1: Sequence 3 | Part A: Cohort 1: Sequence 4 | Part A: Cohort 2: Sequence 1 | Part A: Cohort 2: Sequence 2 | Part A: Cohort 2: Sequence 3 | Part A: Cohort 2: Sequence 4 | Part A: Cohort 3: Fed/Fasted Sequence | Part A: Cohort 3: Fasted/Fed Sequence | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 4 | 2 | 2 | 3 | 2 | 3 | 2 | 4 | 3 | 9 | 8 | 6 | 7 | 8 | 8 | 73 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Part A: Cohort 1: Sequence 1 | Part A: Cohort 1: Sequence 2 | Part A: Cohort 1: Sequence 3 | Part A: Cohort 1: Sequence 4 | Part A: Cohort 2: Sequence 1 | Part A: Cohort 2: Sequence 2 | Part A: Cohort 2: Sequence 3 | Part A: Cohort 2: Sequence 4 | Part A: Cohort 3: Fed/Fasted Sequence | Part A: Cohort 3: Fasted/Fed Sequence | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 6 |
| Male | 2 | 3 | 2 | 2 | 2 | 2 | 3 | 2 | 3 | 2 | 8 | 8 | 6 | 7 | 8 | 7 | 67 |
| Ethnicity (NIH/OMB)(Participants) | Part A: Cohort 1: Sequence 1 | Part A: Cohort 1: Sequence 2 | Part A: Cohort 1: Sequence 3 | Part A: Cohort 1: Sequence 4 | Part A: Cohort 2: Sequence 1 | Part A: Cohort 2: Sequence 2 | Part A: Cohort 2: Sequence 3 | Part A: Cohort 2: Sequence 4 | Part A: Cohort 3: Fed/Fasted Sequence | Part A: Cohort 3: Fasted/Fed Sequence | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 0 | 3 | 0 | 1 | 2 | 1 | 1 | 1 | 3 | 0 | 3 | 2 | 1 | 19 |
| Not Hispanic or Latino | 2 | 4 | 1 | 2 | 0 | 2 | 2 | 0 | 3 | 2 | 8 | 5 | 6 | 4 | 6 | 7 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Part A: Cohort 1: Sequence 1 | Part A: Cohort 1: Sequence 2 | Part A: Cohort 1: Sequence 3 | Part A: Cohort 1: Sequence 4 | Part A: Cohort 2: Sequence 1 | Part A: Cohort 2: Sequence 2 | Part A: Cohort 2: Sequence 3 | Part A: Cohort 2: Sequence 4 | Part A: Cohort 3: Fed/Fasted Sequence | Part A: Cohort 3: Fasted/Fed Sequence | Part B: Pooled Placebo | Part B: Cohort 1: CVL-354 10 mg | Part B: Cohort 2: CVL-354 25 mg | Part B: Cohort 3: CVL-354 50 mg | Part B: Cohort 4: CVL-354 80 mg | Part B: Cohort 5: CVL-354 85 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Asian | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 1 | 2 | 0 | 1 | 1 | 1 | 2 | 0 | 7 | 4 | 5 | 2 | 5 | 4 | 38 |
| White | 0 | 1 | 1 | 0 | 3 | 1 | 2 | 1 | 2 | 2 | 2 | 3 | 1 | 4 | 3 | 2 | 28 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Studies of the drug tested here: Icalcaprant