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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01797198
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 1
Start date April 2012
Completion date June 2012

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