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

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

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Key information

Conditions

Healthy Volunteer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pharmacokinetics of YM178 Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kantou, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YM178

Drug

oral

Other names: mirabegron

Primary outcomes

Plasma concentration of unchanged YM178

Time frame: Up to 96 hours post dose

Secondary outcomes

Urinary concentration of unchanged YM178

Time frame: Up to 96 hours post dose

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Aug 26, 2009
Registry last updated: Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed