Overview

Drug Interaction Study of SAR302503 in Patients With Solid Tumor

Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
Primary Objective: - To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4). - To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses. Secondary Objectives: - To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1 - To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2 - To determine antitumor activity in Segment 2
Phase:
Phase 1
Details
Lead Sponsor:
Sanofi
Treatments:
Metoprolol
Midazolam