drugset / Trial / NCT01762462

Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

NCT01762462

Phase 1 Completed 17 enrolled Bristol-Myers Squibb
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-12
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Fedratinib Small molecule 300 mg Oral

Indications

No indication recorded.