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

July 15, 2013 updated by: Astellas Pharma Inc

A Pharmacokinetic Study in Healthy Non-elderly Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of YM178

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose group
3 way cross-over. Fasting, normal diet and high-fat diet
Drug: YM178
oral
Other Names:
  • mirabegron
Experimental: High dose group
3 way cross-over. Fasting, normal diet and high-fat diet
Drug: YM178
oral
Other Names:
  • mirabegron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of unchanged YM178
Time Frame: Up to 96 hours post dose
Up to 96 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Urinary concentration of unchanged YM178
Time Frame: Up to 96 hours post dose
Up to 96 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Estimate)

July 17, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 178-CL-078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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