NCT01762462

Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatic Impairment

Interventions

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

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-01-07
• Last updated: 2025-03-05

Locations

3 sites across 1 country: United States