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

Multiple Sclerosis Clinical Trial

Official title:

An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046629
• Other study ID #: PKM12788
• Secondary ID: U1111-1152-4217
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2014
• Last updated: August 20, 2014
• Start date: May 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 ß-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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Teriflunomide HMR1726
Pharmaceutical form:tablet Route of administration: oral
• cholestyramine
Pharmaceutical form:power Route of administration: oral

Locations

Country	Name	City	State
China	Investigational Site Number 156001	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters for teriflunomide determined from plasma concentration		5 weeks	No
Secondary	safety assessments (adverse events, laboratory data, vital sign, and ECG parameters)		6 weeks	Yes