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

Completed · Phase 1

Conditions studied: Moderate Hepatic Impairment, Normal Hepatic Function

In brief

The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety.

Key facts

Study ID

NCT02871570

Run by

GlycoMimetics Incorporated

People needed

16

Starts

2016-09-01

Expected to finish

2017-03-01

Last updated by the study team

2020-07-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orlando Clincial Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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