NCT01239459

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

An Open-label Pharmacokinetic and Tolerability Study of Teriflunomide Given as a Single 14 mg Dose in Subjects With Severe Renal Impairment, and in Matched Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The total study duration per subject is 11-15 weeks broken down as follows: * Screening: up to 3 weeks * Hospitalization: 3 days (admission 1 day prior to study drug intake) * Follow-up: 10 -12 weeks

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Teriflunomide HMR1726	Pharmaceutical form:film coated tablet Route of administration: oral administration on Day 1 under fasted condition
DRUG	Cholestyramine	Pharmaceutical form:powder Route of administration: oral administration 3 times per day on Day 54 and 55

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2010-11-11
• Last updated: 2012-03-01

Locations

1 site across 1 country: Germany