Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment
- Registration Number
- NCT01762462
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Primary Objective:
To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of SAR302503.
Secondary Objective:
To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with mild and moderate and hepatic impairment and in matched subjects with normal hepatic function.
- Detailed Description
Study duration=17-35 days
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SAR302503 SAR302503 single treatment with oral dose up to 300 mg of SAR302503
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameter: Cmax, AUClast and AUC 12 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred 12 days Safety parameters including Clinical tests 16 days Safety parameters including laboratory tests 16 days Safety parameters including ECG parameters 16 days Number of subjects with adverse events (AEs) - Time Frame: 16 days
Trial Locations
- Locations (3)
Investigational Site Number 840001
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 840003
🇺🇸Miami, Florida, United States
Investigational Site Number 840002
🇺🇸Orlando, Florida, United States