NCT01763190

Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

An Open-label Pharmacokinetic and Tolerability Study 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	SAR302503	Pharmaceutical form:capsule Route of administration: oral

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-01-08
• Last updated: 2025-03-05

Locations

3 sites across 1 country: United States