Phase 1
Completed N=16
A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Moderate Hepatic Impairment · Normal Hepatic Function
Source: ClinicalTrials.gov NCT02871570 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants With Post-baseline Clinically Significant Findings in Physical Examinations — 0; 0 participants
Summary
The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Post-baseline Clinically Significant Findings in Physical Examinations |
0; 0 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
1; 1; 0; 0 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Summarization Criteria |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Vital Signs Data Meeting Pre-defined Summarization Criteria |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
7; 0 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Rivipansel |
599.7; 770.0 | — |
| PRIMARY Total Clearance From Plasma (CL) of Rivipansel |
1.401; 1.091 | — |
| SECONDARY Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rivipansel |
593.8; 763.7 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Rivipansel |
77.91; 98.06 | — |
| SECONDARY Terminal Half-Life of Rivipansel |
7.653; 7.805 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of Rivipansel |
14.08; 11.20 | — |
Eligibility Criteria
Inclusion Criteria
- Female subjects of non-childbearing potential or male subjects
- Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
- Normal Hepatic function for the healthy subjects
- Stable Hepatic Impairment for the subjects with moderate hepatic impairment
Exclusion Criteria
- Treatment with an investigational drug within 30 days of the dose of study medication
- Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant
- Use of herbal supplements in the 28 days prior to the dose of study medication
- Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication
- A positive urine drug screen for illicit drugs
Data sourced from ClinicalTrials.gov (NCT02871570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.