Clinical trial NCT02046629: A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers
Official title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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.

Primary outcomes:
measure: Pharmacokinetic parameters for teriflunomide determined from plasma concentration
timeFrame: 5 weeks
Secondary outcomes:
measure: safety assessments (adverse events, laboratory data, vital sign, and ECG parameters)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Investigational Site Number 156001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: