NCT00965926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 17, 2013

Status Verified

July 1, 2013

Enrollment Period

2 months

First QC Date

August 24, 2009

Last Update Submit

July 15, 2013

Conditions

Healthy VolunteerPharmacokinetics of YM178

Keywords

Overactive BladderUrinary incontinenceYM178mirabegron

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of unchanged YM178

    Up to 96 hours post dose

Secondary Outcomes (1)

  • Urinary concentration of unchanged YM178

    Up to 96 hours post dose

Study Arms (2)

Low dose group

EXPERIMENTAL

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

Drug: YM178

High dose group

EXPERIMENTAL

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

Drug: YM178

Interventions

YM178DRUG

oral

Also known as: mirabegron
High dose groupLow dose group

Eligibility Criteria

Age20 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kantou, Japan

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 26, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

July 17, 2013

Record last verified: 2013-07

Locations

JP(1)