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Trial record 1 of 1 for:    pkm12788
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A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02046629
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : August 21, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Teriflunomide HMR1726 Drug: cholestyramine Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese Subjects
Study Start Date : May 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: teriflunomide dose 1
Teriflunomide 14mg tablet, oral single dose, fast condition Cholestyramine power, 8 gram,oral three times a day for 4 days, fed condition
Drug: Teriflunomide HMR1726
Pharmaceutical form:tablet Route of administration: oral

Drug: cholestyramine
Pharmaceutical form:power Route of administration: oral

Primary Outcome Measures :
  1. Pharmacokinetic parameters for teriflunomide determined from plasma concentration [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. safety assessments (adverse events, laboratory data, vital sign, and ECG parameters) [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02046629

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Investigational Site Number 156001
Shanghai, China, 200025
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi Identifier: NCT02046629    
Other Study ID Numbers: PKM12788
U1111-1152-4217 ( Other Identifier: UTN )
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cholestyramine Resin
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents