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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Mirabegron
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 23, 2014