A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese Subjects
A Study to Evaluate Pharmacokinetics of Mirabegron After Single and Multiple Oral Administration to Healthy Non-elderly Male and Female Chinese Subjects
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 10, 2012
CompletedFirst Posted
Study publicly available on registry
December 11, 2012
CompletedDecember 11, 2012
December 1, 2012
2 months
December 10, 2012
December 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Safety assessed by the incidence of adverse events, vital signs, lab-test and 12-lead ECGs
Through day 25
Study Arms (1)
mirabegron group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Kyushu, Japan
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2012
First Posted
December 11, 2012
Study Start
August 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
December 11, 2012
Record last verified: 2012-12