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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01747564
First received: December 10, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted

December 10, 2012
December 10, 2012
August 2012
October 2012   (final data collection date for primary outcome measure)
Pharmacokinetic (PK) profile for ASP015K (in plasma): Cmax, AUClast, AUCinf and AUC0-24h [ Time Frame: Day 1-5 and Day 10, 11, 14-21 ] [ Designated as safety issue: No ]
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)
Same as current
No Changes Posted
Safety assessed by the incidence of adverse events, vital signs, lab-test and 12-lead ECGs [ Time Frame: Through day 25 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Healthy Subjects
  • Plasma Concentration of Mirabegron
Drug: YM178 (mirabegron)
oral
Other Name: mirabegron
Experimental: mirabegron group
Intervention: Drug: YM178 (mirabegron)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01747564
178-CL-093
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Medical Director Astellas Pharma Inc
Astellas Pharma Inc
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP