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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlycoMimetics Incorporated; Pfizer

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