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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965926
• Other study ID #: 178-CL-078
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2009
• Last updated: July 15, 2013
• Start date: July 2009
• Est. completion date: September 2009

Study information

• Verified date: July 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 54 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer
• Pharmacokinetics of YM178

Intervention

Drug:
• YM178
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of unchanged YM178		Up to 96 hours post dose	No
Secondary	Urinary concentration of unchanged YM178		Up to 96 hours post dose	No

External Links

•   Link to Results on JAPIC