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

GlycoMimetics

Status and phase: Completed; Phase 1

Conditions: Moderate Hepatic Impairment; Normal Hepatic Function

Treatments: Drug: Rivipansel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02871570

B5201006

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Moderate Hepatic Impairment

Experimental group

Description:

A single dose of IV Rivipansel over 20 minutes

Treatment:

Drug: Rivipansel

Normal Hepatic Function

Experimental group

Description:

A single dose of IV Rivipansel over 20 minutes

Treatment:

Drug: Rivipansel