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CompletedNCT00965926Updated Jul 17, 2013

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

A Phase 1 interventional study of YM178 in Healthy Volunteer and Pharmacokinetics of YM178, sponsored by Astellas Pharma Inc. Completed at 1 site in Japan. Open to participants aged 20 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-17.

Sponsored by Astellas Pharma Inc · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
20 Years to 54 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer
  • Pharmacokinetics of YM178

Keywords

  • Overactive Bladder
  • Urinary incontinence
  • YM178
  • mirabegron
03

In context

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Low dose group

    3 way cross-over. Fasting, normal diet and high-fat diet

    Drug: YM178

  • Experimental
    High dose group

    3 way cross-over. Fasting, normal diet and high-fat diet

    Drug: YM178

Interventions

  • DrugYM178

    oral

    Also known as: mirabegron

06

What researchers measure

Primary outcomes

  1. Plasma concentration of unchanged YM178

    Time frame: Up to 96 hours post dose

Secondary outcomes

  1. Urinary concentration of unchanged YM178

    Time frame: Up to 96 hours post dose

07

Study locations

1 site
  • Kantou, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00965926
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Aug 26, 2009
Start date
Jul 2009
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jul 17, 2013

Study contacts

Use Central Contact
study chair · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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