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

Phase 1

Completed

• Conditions: Healthy Subjects; Plasma Concentration of Mirabegron
• Interventions: Drug: YM178 (mirabegron)

• Registration Number: NCT01747564
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-10
• Last Update Submitted: 2012-12-10
• Study First Posted: 2012-12-11
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mirabegron group	YM178 (mirabegron)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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