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

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects; Plasma Concentration of Mirabegron

Treatments: Drug: YM178 (mirabegron)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01747564

178-CL-093

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 1 patient group

mirabegron group

Experimental group

Treatment:

Drug: YM178 (mirabegron)