NCT00966966

Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered

An Open-Label, Nonrandomized Study To Evaluate The Potential Pharmacokinetic Interaction Between SAM-531 and Gemfibrozil, A Cytochrome P-450 2C8 Inhibitor, When Coadministered Orally To Healthy Young Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SAM-531 and gemfibrozil	2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-08-27
• Last updated: 2010-08-20

Locations

1 site across 1 country: Netherlands