Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment
- Registration Number
- NCT01763190
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Primary Objective:
To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503.
Secondary Objective:
To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.
- Detailed Description
study duration = 17 to 35 days
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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 of 300 mg oral dose of SAR302503
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameter: Cmax, AUClast and AUC 12 days
- Secondary Outcome Measures
Name Time Method Safety parameters including laboratory tests 16 days Safety parameters including ECG parameters 16 days 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 Number of subjects with adverse events (AEs) 16 days
Trial Locations
- Locations (3)
Investigational Site Number 840002
🇺🇸Orlando, Florida, United States
Investigational Site Number 840003
🇺🇸Saint Paul, Minnesota, United States
Investigational Site Number 840001
🇺🇸Knoxville, Tennessee, United States