A Phase 1 interventional study of Rivipansel in Moderate Hepatic Impairment and Normal Hepatic Function, sponsored by GlycoMimetics Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-09.
Sponsored by GlycoMimetics Incorporated · Phase 1, Interventional, and Other
The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →GlycoMimetics Incorporated is the lead sponsor of 17 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female subjects of non-childbearing potential or male subjects
Exclusion Criteria:
A single dose of IV Rivipansel over 20 minutes
Drug: Rivipansel
A single dose of IV Rivipansel over 20 minutes
Drug: Rivipansel
A single dose of IV Rivipansel over 20 minutes
Also known as: GMI-1070
Number of Participants With Post-baseline Clinically Significant Findings in Physical Examinations
A full physical examination was performed for each participant, and it included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes and gastrointestinal, musculoskeletal, and neurological systems. Clinical significance of laboratory findings was determined by the investigator.
Time frame: Day 5
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between administration of study medication and up to follow-up visit (28-31 days after administration) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.
Time frame: Day 1 to follow-up visit (28-31 days after administration of study medication on Day 1)
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Summarization Criteria
Maximum absolute values and increases from baseline were summarized for PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS duration (time from Q wave to the end of S wave, corresponding to ventricle depolarization), and QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval \>=300 msec; (2) QRS duration \>=200 msec; (3) QTcF interval: 450 to \<480 msec; (4) QTcF interval: 480 to \<500 msec; (5) QTcF interval \>=500 msec; (6) PR interval percent increase from baseline \>=25/50 percent; (7) QRS duration percent increase from baseline \>=50 percent; (8) QTcF interval increase from baseline: 30 to \<60 msec; (9) QTcF interval increase from baseline \>=60 msec.
Time frame: Day 5
Number of Participants With Vital Signs Data Meeting Pre-defined Summarization Criteria
Absolute values and changes from baseline (increase and decrease) were summarized for supine diastolic blood pressure (DBP), supine systolic blood pressure (SBP), and supine pulse rate. Number of participants with vital signs findings meeting the following criteria is presented: (1) supine DBP \<50 millimeters of mercury (mm Hg); (2) supine DBP \>90 mm Hg; (3) supine SBP \<90 mm Hg; (4) supine SBP \>140 mm Hg (for normal hepatic function group); (5) supine SBP \>160 mm Hg (for moderate hepatic impairment group); (6) supine pulse rate \< 40 beats per minute (bpm); (7) supine pulse rate \>120 bpm; (8) supine DBP increase from baseline \>=20 mm Hg; (9) supine SBP increase from baseline \>=30 mmHg; (10) supine DBP decrease from baseline \>=20 mm Hg; (11) supine SBP decrease from baseline \>=30 mm Hg.
Time frame: Day 1 to Day 5
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Laboratory tests included: hematology (hemoglobin, hematocrit, red and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, prothrombin time/international normalized ratio), chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate and alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (pH, qualitative glucose, protein, and blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, and microscopy), and other tests (follicle stimulating hormone, urine drug test and serologic tests on human immunodeficiency virus-1 antibody, Hepatitis B surface antigen and hepatitis C antibody). Abnormality was determined by the investigator using widely accepted criteria in clinical practice.
Time frame: Day 5
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Rivipansel
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log linear regression analysis, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
Total Clearance From Plasma (CL) of Rivipansel
CL of rivipansel was calculated as dose/AUCinf, where AUCinf referred to the area under the plasma concentration-time profile from time 0 extrapolated to the infinite time.
Time frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rivipansel
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of rivipansel was determined using a linear/log trapezoidal method.
Time frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
Maximum Observed Concentration (Cmax) of Rivipansel
Time frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
Terminal Half-Life of Rivipansel
Terminal half-life of rivipansel was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Time frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
Volume of Distribution at Steady State (Vss) of Rivipansel
Vss of rivipansel was calculated as CL\*MRT, where MRT was the mean residence time and CL was the clearance from plasma.
Time frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
Time for Maximum Observed Concentration (Tmax) of Rivipansel
Time frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
| Milestone | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
A full physical examination was performed for each participant, and it included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes and gastrointestinal, musculoskeletal, and neurological systems. Clinical significance of laboratory findings was determined by the investigator.
| participants | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Number of Participants With Post-baseline Clinically Significant Findings in Physical Examinations | 0 | 0 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between administration of study medication and up to follow-up visit (28-31 days after administration) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.
| participants | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| AEs | 1 | 1 |
| SAEs | 0 | 0 |
Maximum absolute values and increases from baseline were summarized for PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS duration (time from Q wave to the end of S wave, corresponding to ventricle depolarization), and QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval \>=300 msec; (2) QRS duration \>=200 msec; (3) QTcF interval: 450 to \<480 msec; (4) QTcF interval: 480 to \<500 msec; (5) QTcF interval \>=500 msec; (6) PR interval percent increase from baseline \>=25/50 percent; (7) QRS duration percent increase from baseline \>=50 percent; (8) QTcF interval increase from baseline: 30 to \<60 msec; (9) QTcF interval increase from baseline \>=60 msec.
| participants | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| PR interval >=300 msec | 0 | 0 |
| QRS duration >=200 msec | 0 | 0 |
| QTcF interval: 450 to <480 msec | 1 | 0 |
| QTcF interval: 480 to <500 msec | 0 | 0 |
| QTcF interval >=500 msec | 0 | 0 |
| PR interval increase from baseline >=25/50 percent | 0 | 0 |
| QRS duration increase from baseline >=50 percent | 0 | 0 |
| QTcF increase from baseline: 30 to <60 msec | 0 | 0 |
| QTcF interval increase from baseline >=60 msec | 0 | 0 |
Absolute values and changes from baseline (increase and decrease) were summarized for supine diastolic blood pressure (DBP), supine systolic blood pressure (SBP), and supine pulse rate. Number of participants with vital signs findings meeting the following criteria is presented: (1) supine DBP \<50 millimeters of mercury (mm Hg); (2) supine DBP \>90 mm Hg; (3) supine SBP \<90 mm Hg; (4) supine SBP \>140 mm Hg (for normal hepatic function group); (5) supine SBP \>160 mm Hg (for moderate hepatic impairment group); (6) supine pulse rate \< 40 beats per minute (bpm); (7) supine pulse rate \>120 bpm; (8) supine DBP increase from baseline \>=20 mm Hg; (9) supine SBP increase from baseline \>=30 mmHg; (10) supine DBP decrease from baseline \>=20 mm Hg; (11) supine SBP decrease from baseline \>=30 mm Hg.
| participants | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| supine DBP <50 mm Hg | 0 | 0 |
| supine DBP >90 mm Hg | 0 | 0 |
| supine SBP <90 mm Hg | 0 | 0 |
| supine SBP >140 mm Hg (normal function group) | — | 0 |
| supine SBP >160 mm Hg (moderate impairment group) | 0 | — |
| supine pulse rate <40 bpm | 0 | 0 |
| supine pulse rate >120 bpm | 0 | 0 |
| supine DBP increase from baseline >=20 mm Hg | 1 | 0 |
| supine SBP increase from baseline >=30 mmHg | 1 | 0 |
| supine DBP decrease from baseline >=20 mm Hg | 0 | 0 |
| supine SBP decrease from baseline >=30 mm Hg | 0 | 0 |
Laboratory tests included: hematology (hemoglobin, hematocrit, red and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, prothrombin time/international normalized ratio), chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate and alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (pH, qualitative glucose, protein, and blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, and microscopy), and other tests (follicle stimulating hormone, urine drug test and serologic tests on human immunodeficiency virus-1 antibody, Hepatitis B surface antigen and hepatitis C antibody). Abnormality was determined by the investigator using widely accepted criteria in clinical practice.
| participants | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | 7 | 0 |
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log linear regression analysis, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
| hour*microgram/milliliter (hr*mcg/mL) | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Rivipansel | 599.7 ± 25 | 770.0 ± 14 |
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of rivipansel was determined using a linear/log trapezoidal method.
| hr*mcg/mL | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rivipansel | 593.8 ± 26 | 763.7 ± 14 |
CL of rivipansel was calculated as dose/AUCinf, where AUCinf referred to the area under the plasma concentration-time profile from time 0 extrapolated to the infinite time.
| liter/hour | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Total Clearance From Plasma (CL) of Rivipansel | 1.401 ± 26 | 1.091 ± 14 |
| mcg/mL | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Rivipansel | 77.91 ± 38 | 98.06 ± 28 |
Terminal half-life of rivipansel was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
| hours | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Terminal Half-Life of Rivipansel | 7.653 ± 0.964 | 7.805 ± 0.923 |
Vss of rivipansel was calculated as CL\*MRT, where MRT was the mean residence time and CL was the clearance from plasma.
| liters | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Volume of Distribution at Steady State (Vss) of Rivipansel | 14.08 ± 29 | 11.20 ± 14 |
| hours | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Time for Maximum Observed Concentration (Tmax) of Rivipansel | 0.667 (0.667 to 3.33) | 0.667 (0.667 to 0.667) |
Collected over Day 1 to follow-up visit (28-31 days after administration of study medication on Day 1). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate Hepatic Impairment Group | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Normal Hepatic Function Group | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Event | Moderate Hepatic Impairment Group | Normal Hepatic Function Group |
|---|---|---|
| Abdominal discomfortGastrointestinal disorders | 1/8 | 0/8 |
| RashSkin and subcutaneous tissue disorders | 0/8 | 1/8 |
Baseline analysis population included all participants who received study treatment.
| Age, Continuous(years) | Moderate Hepatic Impairment Group | Normal Hepatic Function Group | Total |
|---|---|---|---|
| Mean | 58.00 ± 3.85 | 58.75 ± 4.43 | 58.38 ± 4.03 |
| Sex: Female, Male(Participants) | Moderate Hepatic Impairment Group | Normal Hepatic Function Group | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 7 | 7 | 14 |
| Race (NIH/OMB)(Participants) | Moderate Hepatic Impairment Group | Normal Hepatic Function Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 8 | 6 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlycoMimetics Incorporated