Kyushu, Japan
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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Notify MeKey information
Age range
20 year–44 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
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)
Drugoral
Other names: mirabegron
Primary outcomes
-
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
-
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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