A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects

GlycoMimetics

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Impairment

Treatments: Drug: Rivipansel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02813798

B5201005

Details and patient eligibility

About

The purpose of this study is to determine the effect of renal impairment on rivipansel.

Enrollment: 28 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
• Stable renal function

Exclusion criteria

• A positive urine drug screen for illicit drugs
• 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
• Requiring dialysis

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Mild Renal Impairment

Experimental group

Description:

A single dose of IV Rivipansel over 20 minutes

Treatment:

Drug: Rivipansel

Moderate Renal Impairment

Experimental group

Description:

A single dose of IV Rivipansel over 20 minutes

Treatment:

Drug: Rivipansel

Severe Renal Impairment

Experimental group

Description:

A single dose of IV Rivipansel over 20 minutes

Treatment:

Drug: Rivipansel

Normal Renal Functions

Experimental group

Description:

A single dose of IV Rivipansel over 20 minutes

Treatment:

Drug: Rivipansel