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

G

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)

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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