A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers

NCT ID: NCT02046629

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-07-31

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

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

teriflunomide dose 1

Teriflunomide 14mg tablet, oral single dose, fast condition Cholestyramine power, 8 gram,oral three times a day for 4 days, fed condition

Group Type: EXPERIMENTAL

Teriflunomide HMR1726

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

cholestyramine

Intervention Type: DRUG

Pharmaceutical form:power Route of administration: oral

Interventions

Teriflunomide HMR1726

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

cholestyramine

Pharmaceutical form:power Route of administration: oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Male or female subjects, between 18 and 45 years of age, inclusive. Body weight between 50.0 and 95.0 kg, inclusive, if male, and between 45.0 and 85.0 kg, inclusive, if female, body mass index between 19.0 and 24.0 kg/m2, inclusive.

Certified as healthy by a comprehensive clinical assessment and lab test. Subject must use an appropriate contraception method. Having given written informed consent prior to any procedure related to the study.

Exclusion Criteria

Blood donation, any volume, within 3 months before inclusion. Symptomatic postural hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from the supine to the standing position.

Excessive consumption of beverages with xanthine bases (>4 cups or glasses per day).

If female, pregnancy (defined as positive β-hCG blood test), breast-feeding. Any medication (including St John's Wort and traditional Chinese herb medicine) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days.

Any consumption of citrus (grapefruit, orange, etc) or their juices within 5 days before inclusion.

Subject (both male and female) who disagrees to use an appropriate contraception method .

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 156001

Shanghai, , China

Countries

China

Other Identifiers

U1111-1152-4217

Identifier Type: OTHER

Identifier Source: secondary_id

PKM12788

Identifier Type: -

Identifier Source: org_study_id