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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747564
• Other study ID #: 178-CL-093
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2012
• Last updated: December 10, 2012
• Start date: August 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 44 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Subjects
• Plasma Concentration of Mirabegron

Intervention

Drug:
• YM178 (mirabegron)
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24h	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)	Day 1-5 and Day 10, 11, 14-21	No
Secondary	Safety assessed by the incidence of adverse events, vital signs, lab-test and 12-lead ECGs		Through day 25	No