drugset / Trial / NCT01239459

Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment

NCT01239459

Phase 1 Completed 16 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelBasic science

Summary

Primary Objective: \- To determine the effect of severe renal impairment on the pharmacokinetic profile of teriflunomide administered as a single 14 mg dose as compared to healthy subjects Secondary Objective: \- To assess the tolerability of teriflunomide administered as a single 14 mg dose in subjects with severe renal impairment compared to subjects with normal renal function.

Timeline

Start
2010-11
Primary completion
2011-02
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Teriflunomide Small molecule 14 mg Oral
Background Cholestyramine Other / unclassified Oral