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

Status:	Completed
Conditions:	Healthy Studies, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:	Nephrology / Urology, Other
Healthy:	No
Age Range:	18 - 75
Updated:	5/11/2018
Start Date:	June 27, 2016
End Date:	February 21, 2018

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

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

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

We found this trial at

sites

Orlando Clinical Research Center

5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806

407-240-7878