An Open-label Pharmacokinetic and Tolerability Study of SAR302503 Given as a Single 300 mg Dose in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function

Bristol-Myers Squibb3 sites in 1 country36 target enrollmentNovember 2012

ConditionsRenal Impairment

InterventionsSAR302503

DrugsSAR302503

Overview

Phase: Phase 1
Intervention: SAR302503
Conditions: Renal Impairment
Sponsor: Bristol-Myers Squibb
Enrollment: 36
Locations: 3
Primary Endpoint: Pharmacokinetic parameter: Cmax, AUClast and AUC
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary Objective:

To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503.

Secondary Objective:

To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.

Detailed Description

study duration = 17 to 35 days

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

July 2013

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

SAR302503

single treatment of 300 mg oral dose of SAR302503

Intervention: SAR302503

Outcomes

Primary Outcomes

Pharmacokinetic parameter: Cmax, AUClast and AUC

Time Frame: 12 days

Secondary Outcomes

Safety parameters including laboratory tests(16 days)
Safety parameters including ECG parameters(16 days)
Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred(12 days)
Safety parameters including Clinical tests(16 days)
Number of subjects with adverse events (AEs)(16 days)