NCT01797198

A Study to Assess the Effect of Multiple Doses of Gemfribozil on a Single Dose of ASP3652, and to Assess the Effects of Multiple Doses of ASP3652 on a Single Dose of Repaglinide in the Body of Healthy Subjects

An Open Label, Drug-drug Interaction Study to Assess the Effect of Multiple Doses of Gemfibrozil on the Single Dose Pharmacokinetics of ASP3652 and to Assess the Effect of Multiple Doses of ASP3652 on the Single Dose Pharmacokinetics of Repaglinide

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This is a two-part study to investigate the drug-drug potential of ASP3652. Part I of the study evaluates the effect of gemfibrozil twice daily on the single dose of ASP3652. Part 2 evaluates the effect of multiple doses of ASP3652 twice daily on the single dose of repaglinide. Subjects participating in one part of the study may not participate in the other part.

Detailed description

Part 1: On Day 1, a single dose of ASP3652 is administered. After a wash-out period of 3 days, bid (twice daily) dosing of gemfibrozil starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of gemfibrozil administration), a single dose of ASP3652 is administered one hour after the morning dose of gemfibrozil. Part 2: On Day 1, a single dose of repaglinide is administered. After a wash-out period of 3 days, bid dosing of ASP3652 starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of ASP3652 administration), a single dose of repaglinide is administered one hour after the morning dose of ASP3652.

Conditions

• Drug-Drug Interaction (DDI)
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ASP3652	Oral
DRUG	Gemfibrozil	Oral
DRUG	Repaglinide	Oral

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2013-02-22
• Last updated: 2013-02-22

Locations

1 site across 1 country: United Kingdom