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

Astellas

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics of YM178; Healthy Volunteer

Treatments: Drug: YM178

Study type: Interventional

Funder types: Industry

Identifiers

NCT00965926

178-CL-078

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 20 to 54 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

72 participants in 2 patient groups

Low dose group

Experimental group

Description:

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

Treatment:

Drug: YM178

High dose group

Experimental group

Description:

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

Treatment:

Drug: YM178