drugset / Trial / NCT01763190

Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

NCT01763190

Phase 1 Completed 36 enrolled Bristol-Myers Squibb
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-11
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Fedratinib Small molecule 300 mg Oral