NCT02813798

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

A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE DOSE STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF RIVIPANSEL (PF-06460031) IN SUBJECTS WITH RENAL IMPAIRMENT AND IN HEALTHY SUBJECTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: GlycoMimetics Incorporated · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Renal Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	Rivipansel	A single 840mg dose of Rivipansel over 20 minutes

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-06-27
• Last updated: 2020-06-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study