A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers
Phase 1
Completed
- Conditions
- Multiple Sclerosis
- Interventions
- Registration Number
- NCT02046629
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess the pharmacokinetic (PK) parameters of teriflunomide after a single oral dose of 14 mg administration in Chinese healthy subjects
Secondary Objective:
To assess the safety and tolerability after a single oral dose of 14 mg teriflunomide in Chinese healthy subjects
- Detailed Description
* Screening: 2 to 21 days before inclusion (Day -21 to Day -2)
* Institutionalization period: 6 days including 1 treatment day (Day -1 to Day 6, treatment on Day 1)
* Follow-up: 7-10 days (may be extended)
* End of study: Day 38 to Day 41 (may be extended)
* Total study duration: maximum 9 weeks
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description teriflunomide dose 1 Teriflunomide HMR1726 Teriflunomide 14mg tablet, oral single dose, fast condition Cholestyramine power, 8 gram,oral three times a day for 4 days, fed condition teriflunomide dose 1 cholestyramine Teriflunomide 14mg tablet, oral single dose, fast condition Cholestyramine power, 8 gram,oral three times a day for 4 days, fed condition
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters for teriflunomide determined from plasma concentration 5 weeks
- Secondary Outcome Measures
Name Time Method safety assessments (adverse events, laboratory data, vital sign, and ECG parameters) 6 weeks
Trial Locations
- Locations (1)
Investigational Site Number 156001
🇨🇳Shanghai, China