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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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

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Drug-Drug Interaction (DDI) Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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gemfibrozil + ASP3652

Multiple doses of gemfibrozil and single dose of ASP3652

Group Type EXPERIMENTAL

ASP3652

Intervention Type DRUG

Oral

Gemfibrozil

Intervention Type DRUG

Oral

ASP3652 + repaglinide

Multiple doses of ASP3652 and the single dose of repaglinide

Group Type EXPERIMENTAL

ASP3652

Intervention Type DRUG

Oral

Repaglinide

Intervention Type DRUG

Oral

Interventions

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ASP3652

Oral

Intervention Type DRUG

Gemfibrozil

Oral

Intervention Type DRUG

Repaglinide

Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes