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

Sanofi

Status and phase

Completed

Phase 1

Conditions

Multiple Sclerosis

Treatments

Drug: cholestyramine

Drug: Teriflunomide HMR1726

Study type

Interventional

Funder types

Industry

Identifiers

NCT02046629

U1111-1152-4217 (Other Identifier)

PKM12788

Details and patient eligibility

About

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

Full 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

Enrollment

12 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.