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

A Study to Evaluate Pharmacokinetics of Mirabegron After Single and Multiple Oral Administration to Healthy Non-elderly Male and Female Chinese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01747564

Enrollment

Registered

2012-12-11

Start date

2012-08-31

Completion date

2012-10-31

Last updated

2012-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects, Plasma Concentration of Mirabegron

Keywords

Pharmacokinetics, Mirabegron, Phase 1, YM178

Brief summary

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

Detailed description

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.

Interventions

DRUGYM178 (mirabegron)

oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 44 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24h	Day 1-5 and Day 10, 11, 14-21	Maximum concentration (Cmax), Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and AUC from time 0 to 24hr (AUC0-24h)

Secondary

Measure	Time frame
Safety assessed by the incidence of adverse events, vital signs, lab-test and 12-lead ECGs	Through day 25

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026