A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00965926
First received: August 24, 2009
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of YM178 in healthy, non-elderly adult subjects.


Condition Intervention Phase
Healthy Volunteer
Pharmacokinetics of YM178
Drug: YM178
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Pharmacokinetic Study in Healthy Non-elderly Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of YM178

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Plasma concentration of unchanged YM178 [ Time Frame: Up to 96 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary concentration of unchanged YM178 [ Time Frame: Up to 96 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: July 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose group
3 way cross-over. Fasting, normal diet and high-fat diet
Drug: YM178
oral
Other Name: mirabegron
Experimental: High dose group
3 way cross-over. Fasting, normal diet and high-fat diet
Drug: YM178
oral
Other Name: mirabegron

  Eligibility

Ages Eligible for Study:   20 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests
  • Body weight (at screening); female ≥40.0 kg, <70.0 kg, male ≥50.0 kg, <80.0 kg
  • BMI (at screening): ≥17.6, <26.4
  • Written informed consent has been obtained

Exclusion Criteria:

  • Received any investigational drugs within 120 days before the screening test
  • 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 test
  • Received medication within 7 days before hospital admission or is scheduled to receive medication
  • Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period
  • History of drug allergies
  • Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before hospital admission
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965926

Locations
Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00965926     History of Changes
Other Study ID Numbers: 178-CL-078
Study First Received: August 24, 2009
Last Updated: July 15, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Overactive Bladder
Urinary incontinence
YM178
mirabegron

ClinicalTrials.gov processed this record on April 17, 2014