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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00965926
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : July 17, 2013
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteer Pharmacokinetics of YM178 Drug: YM178 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : July 2009
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Plasma concentration of unchanged YM178 [ Time Frame: Up to 96 hours post dose ]

Secondary Outcome Measures :
  1. Urinary concentration of unchanged YM178 [ Time Frame: Up to 96 hours post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965926


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

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00965926     History of Changes
Other Study ID Numbers: 178-CL-078
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: July 17, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents