A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers
An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese Subjects
2 other identifiers
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 multiple-sclerosis
Started May 2014
Shorter than P25 for phase_1 multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 21, 2014
August 1, 2014
2 months
January 23, 2014
August 20, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic parameters for teriflunomide determined from plasma concentration
5 weeks
Secondary Outcomes (1)
safety assessments (adverse events, laboratory data, vital sign, and ECG parameters)
6 weeks
Study Arms (1)
teriflunomide dose 1
EXPERIMENTALTeriflunomide 14mg tablet, oral single dose, fast condition Cholestyramine power, 8 gram,oral three times a day for 4 days, fed condition
Interventions
Pharmaceutical form:tablet Route of administration: oral
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Excessive consumption of beverages with xanthine bases (\>4 cups or glasses per day).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Investigational Site Number 156001
Shanghai, 200025, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2014
First Posted
January 28, 2014
Study Start
May 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 21, 2014
Record last verified: 2014-08