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

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects; Drug-Drug Interaction (DDI)

Treatments: Drug: Repaglinide; Drug: Gemfibrozil; Drug: ASP3652

Study type: Interventional

Funder types: Industry

Identifiers

NCT01797198

2011-002874-21 (EudraCT Number)

3652-CL-0006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

gemfibrozil + ASP3652

Experimental group

Description:

Multiple doses of gemfibrozil and single dose of ASP3652

Treatment:

Drug: ASP3652

Drug: Gemfibrozil

ASP3652 + repaglinide

Experimental group

Description:

Multiple doses of ASP3652 and the single dose of repaglinide

Treatment:

Drug: ASP3652

Drug: Repaglinide