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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: Teriflunomide HMR1726; Drug: Cholestyramine

• Registration Number: NCT01239459
• Lead Sponsor: Sanofi

Brief 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

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-28
• Last Update Posted: 2012-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe impaired renal function	Teriflunomide HMR1726	Subjects with severe renal impairment as defined by Cockroft-Gault formula
Severe impaired renal function	Cholestyramine	Subjects with severe renal impairment as defined by Cockroft-Gault formula
Normal renal function	Teriflunomide HMR1726	Subjects with normal renal function as defined by Cockroft-Gault formula
Normal renal function	Cholestyramine	Subjects with normal renal function as defined by Cockroft-Gault formula

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of Teriflunomide determined from plasma concentration (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))	56 days

Secondary Outcome Measures

Name	Time	Method
Clinical safety evaluation (AE reporting, laboratory tests (hematology, biochemistry and urinalysis), vital signs and ECG parameters)	Up to 12 weeks (until the end of study visit)

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇩🇪 Berlin, Germany