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A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese Subjects

NCT ID: NCT01747564

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.

Detailed Description

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This study is an open-label study. The subjects will receive single administration of mirabegron in a fasted condition. After the non-dosing period, subjects will receive mirabegron for 8 days.

Conditions

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Healthy Subjects Plasma Concentration of Mirabegron

Keywords

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Pharmacokinetics Mirabegron Phase 1 YM178

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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mirabegron group

Group Type EXPERIMENTAL

YM178 (mirabegron)

Intervention Type DRUG

oral

Interventions

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YM178 (mirabegron)

oral

Intervention Type DRUG

Other Intervention Names

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mirabegron

Eligibility Criteria

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Inclusion Criteria

* Body weight: (male) over 50.0kg and less than 80.0kg (female) over 40.0kg and less than 70.0kg
* Body Mass Index: over 17.6 and less than 26.4 kg/m
* Chinese subjects
* Healthy judged by investigator or sub-investigator

Exclusion Criteria

* Received any investigational drugs within 120 days before the screening assessment
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
* Received medication within 7 days before hospital admission
* A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
* History of drug allergies
* With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
* Received mirabegron beforehand
* Glaucoma patient
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Kyushu, , Japan

Site Status

Countries

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Japan

Other Identifiers

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178-CL-093

Identifier Type: -

Identifier Source: org_study_id