Status:
COMPLETED
Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment
Lead Sponsor:
Sanofi
Conditions:
Renal Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Primary Objective: \- To determine the effect of severe renal impairment on the pharmacokinetic profile of teriflunomide administered as a single 14 mg dose as compared to healthy subjects Secondary...
Detailed Description
The total study duration per subject is 11-15 weeks broken down as follows: * Screening: up to 3 weeks * Hospitalization: 3 days (admission 1 day prior to study drug intake) * Follow-up: 10 -12 weeks
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects with renal impairment:
- Male subject between 18 and 75 years of age inclusive and postmenopausal female between 45 and 75 years of age inclusive.
- Chronic severe renal impairment as defined by Cockroft-Gault formula (creatinine clearance (CLcr) \< 30mL/min, but not requiring hemodialysis).
- Laboratory parameters within the acceptable range for subjects with renal impairment; in particular, hepatic enzymes (ALT, AST) and bilirubin should be \< 2 x upper limit of normal range and neutrophils should be within normal ranges.
- Matched healthy subjects:
- Male subject between 18 and 75 years of age inclusive and postmenopausal female between 45 and 75 years of age inclusive, matched by age.
- Body weight within 15% of the body weight of the subjects with renal impairment to be matched and Body Mass Index between 18.0 and 30.0 mg/kg2 inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal renal function as defined by Cockroft-Gault formula (creatinine clearance (CLcr) \> 80mL/min)
- Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (AST, ALT), bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper limit of normal range.
- Exclusion criteria:
- Subjects with renal impairment:
- Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness.
- Active hepatitis, hepatic insufficiency.
- Acute renal failure (de novo or superimposed to pre-existing chronic renal impairment), nephrotic syndrome.
- Subject requiring dialysis during the study.
- Any significant change in chronic treatment medication within 14-days before inclusion.
- Any drug, which could impact by any mechanism of action, the pharmacokinetic of the investigational product.
- Positive reaction to Human Immunodeficiency Virus (HIV) tests: anti-HIV1 antibodies, anti-HIV2 antibodies
- Positive results on urine drug screen (amphetamines / methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates) unless this result is secondary to a documented medical prescription.
- Positive alcohol test.
- Man who disagrees to use a double barrier method of contraception with their partner during the study.
- Matched healthy subjects:
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- For subjects 50 years old and below:
- any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic halflife of that drug, whichever the longest, with the exception of menopausal hormone replacement therapy.
- any significant change in chronic treatment medication within 14-days before inclusion.
- Any drug, which could impact by any mechanism of action, the pharmacokinetic of the investigational product.
- Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, antihepatitis C virus (anti-HCV) antibodies, HIV1 antibodies, anti-HIV2 antibodies.
- Positive results on urine drug screen (amphetamines / methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol test.
- Man who disagrees to use a double barrier method of contraception with their partner during the study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01239459
Start Date
November 1 2010
End Date
March 1 2011
Last Update
March 1 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Berlin, Germany