NCT01762462CompletedPhase 1
An Open-label, Pharmacokinetic and Tolerability Study of SAR302503 Given as a Single 300 mg Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function
Bristol-Myers Squibb3 sites in 1 country17 target enrollmentStarted: December 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 3
- Primary Endpoint
- Pharmacokinetic parameter: Cmax, AUClast and AUC
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SAR302503
Experimental
single treatment with oral dose up to 300 mg of SAR302503
Intervention: SAR302503 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic parameter: Cmax, AUClast and AUC
Time Frame: 12 days
Secondary Outcomes
- 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)
Investigators
Study Sites (3)
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