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

Healthy Subjects Clinical Trial

Official title:

An Open Label, Drug-drug Interaction Study to Assess the Effect of Multiple Doses of Gemfibrozil on the Single Dose Pharmacokinetics of ASP3652 and to Assess the Effect of Multiple Doses of ASP3652 on the Single Dose Pharmacokinetics of Repaglinide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797198
• Other study ID #: 3652-CL-0006
• Secondary ID: 2011-002874-21
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2013
• Last updated: February 20, 2013
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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, ?-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.

Study Design

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

Related Conditions & MeSH terms

• Drug-Drug Interaction (DDI)
• Healthy Subjects

Intervention

Drug:
• ASP3652
Oral
• Gemfibrozil
Oral
• Repaglinide
Oral

Locations

Country	Name	City	State
United Kingdom	PAREXEL Early Phase Clinical Unit	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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)	No
Secondary	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)	Part 1: tmax, tlag, t1/2, Vz/F, CL/F, Cmax, morning and evening Ctrough, tmax, AUCtau and CL/F	Days 1-11	No
Secondary	Effect of multiple doses of ASP3652 on the PK of a single dose of repaglinide	Part 2: tmax, tlag, t1/2, Vz/F, CL/F, Cmax, morning and evening Ctrough, tmax, AUCtau and CL/F	Days 1-10	No
Secondary	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	Part 2: Baseline blood glucose concentration, minimum blood glucose concentration, and mean blood glucose concentration from 0 to 9h after dosing of repaglinide	Days 1-10	No