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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01747564
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Plasma Concentration of Mirabegron Drug: YM178 (mirabegron) Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Study to Evaluate Pharmacokinetics of Mirabegron After Single and Multiple Oral Administration to Healthy Non-elderly Male and Female Chinese Subjects
Study Start Date : August 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Arm Intervention/treatment
Experimental: mirabegron group Drug: YM178 (mirabegron)
Other Name: mirabegron

Primary Outcome Measures :
  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 Outcome Measures :
  1. Safety assessed by the incidence of adverse events, vital signs, lab-test and 12-lead ECGs [ Time Frame: Through day 25 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01747564

Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Medical Director Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc Identifier: NCT01747564     History of Changes
Other Study ID Numbers: 178-CL-093
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Astellas Pharma Inc:
Phase 1

Additional relevant MeSH terms:
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents