Status:
COMPLETED
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
Lead Sponsor:
Astellas Pharma Europe B.V.
Conditions:
Drug-Drug Interaction (DDI)
Healthy Subjects
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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 gem...
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 ...
Eligibility Criteria
Inclusion
- Subject is white and of Caucasian origin.
- Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
- Male subjects must agree to practice an effective contraceptive method with female sexual partners to prevent pregnancy.
Exclusion
- Known or suspected hypersensitivity to ASP3652, repaglinide and/or gemfibrozil, or any components of the formulation used.
- Any of the liver function tests (ALT, AST, γ-GT, TBL and ALP) above the upper limit of normal. In such case the sample may be repeated once.
- Regular use of any inducer of metabolism (e.g. barbiturates, Rifampicin) in the 3 months prior to admission to the Clinical Unit.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01797198
Start Date
April 1 2012
End Date
June 1 2012
Last Update
February 22 2013
Active Locations (1)
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1
PAREXEL Early Phase Clinical Unit
Harrow, United Kingdom, HA1 3U