Drug-drug Interaction Study With ASP1941 and Glimepiride

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01302158

Collaborator

(none)

Enrollment

Location

Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: ASP1941 Drug: Glimepiride	Phase 1

Detailed Description

Study includes two parts. Part A is to investigate the effect of multiple oral doses of ASP1941 on the pharmacokinetics of glimepiride, and Part B is to investigate the effect of multiple oral doses of glimepiride on the pharmacokinetics of ASP1941.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-label, Randomized Crossover Study to Evaluate the Effect of ASP1941 on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glimepiride in Healthy Subjects and Vice Versa

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Outcome Measures

Primary Outcome Measures

Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride [14 days]

Secondary Outcome Measures

Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941 [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI between 18.5 and 30 kg/m2, inclusive

Exclusion Criteria:

Any of the liver function tests above the upper limit of normal
Pulse <40 or >90 bpm; Systolic Blood Pressure >140 mmHg; Diastolic Blood Pressure > 90 mmHg