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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


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
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