drugset / Trial / NCT01239459
Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Teriflunomide | Small molecule | 14 mg | Oral |
| Background | Cholestyramine | Other / unclassified | — | Oral |