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NCT Number: NCT01747564

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

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

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Key information

Age range

20 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyushu, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YM178 (mirabegron)

Drug

oral

Other names: mirabegron

Primary outcomes

  1. Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24h

    Time frame: 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 outcomes

  1. Safety assessed by the incidence of adverse events, vital signs, lab-test and 12-lead ECGs

    Time frame: Through day 25

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 11, 2012
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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