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

NCT01797198 | Completed Phase 1

• 2 other identifiers: 3652-CL-00062011-002874-21
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Drug-Drug Interaction (DDI); Healthy Subjects

Keywords

Phase I; ASP3652; Gemfibrozil; Repaglinide; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Effect of multiple doses of gemfibrozil on the Pharmacokinetics (PK) of a single dose of ASP3652 (plasma) and metabolites H1/H2/H3

  Part 1: Maximum concentration (Cmax), AUClast and AUCinf

  Days 1 - 11

• Effect of multiple doses of ASP3652 on the PK of a single dose of repaglinide and metabolite M4 (plasma)

  Part 2: Cmax, AUClast, AUCinf, and the ratio AUC(M4) / AUC(repaglinide)

  Days 1 - 10

• Assess the safety of single and multiple doses of ASP3652 alone and in combination with gemfibrozil or repaglinide

  Both Parts: Vital signs, physical examination, adverse events, electrocardiogram, clinical laboratory assessments, body temperature, Bond and Lader Visual Analogue Scale (VAS) questionnaire, Physician's Withdrawal Checklist (PWC)

  Screening - End of Study Visit (7-14 days after (early) discharge)

Secondary Outcomes (3)

• Effect of multiple doses of gemfibrozil on the PK of a single dose of ASP3652 (plasma), metabolites H1/H2/H3 and Parent gemfibrozil and gemfibrozil-1-O-ß-glucuronide (plasma)

  Days 1-11

• Effect of multiple doses of ASP3652 on the PK of a single dose of repaglinide

  Days 1-10

• Effect of ASP3652 on the Pharmacodynamics (PD) of repaglinide by comparing the effect of repaglinide on blood glucose levels in the presence and absence of ASP3652

  Days 1-10

Study Arms (2)

gemfibrozil + ASP3652

EXPERIMENTAL

Multiple doses of gemfibrozil and single dose of ASP3652

Drug: ASP3652; Drug: Gemfibrozil

ASP3652 + repaglinide

EXPERIMENTAL

Multiple doses of ASP3652 and the single dose of repaglinide

Drug: ASP3652; Drug: Repaglinide

Interventions

ASP3652 DRUG

Oral

ASP3652 + repaglinide; gemfibrozil + ASP3652

Gemfibrozil DRUG

Oral

gemfibrozil + ASP3652

Repaglinide DRUG

Oral

ASP3652 + repaglinide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (1)

PAREXEL Early Phase Clinical Unit

Harrow, HA1 3U, United Kingdom

Location

MeSH Terms

Interventions

ASP3652; Gemfibrozil; repaglinide

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 22, 2013
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

GB (1)