Multiple Sclerosis
Conditions
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
Interventions
Pharmaceutical form:tablet Route of administration: oral
DRUGcholestyramine
Pharmaceutical form:power Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters for teriflunomide determined from plasma concentration | 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| safety assessments (adverse events, laboratory data, vital sign, and ECG parameters) | 6 weeks |
Countries
China
Outcome results
None listed