Drug-drug Interaction Study With ASP1941 and Glimepiride

Astellas Pharma Inc52 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

ASP1941DRUG

oral

GlimepirideDRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Groningen, Netherlands

Outcomes

Primary Outcomes

Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride

Time frame: 14 days

Secondary Outcomes

Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941

Time frame: 14 days

Data from ClinicalTrials.gov

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