A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150

NCT ID: NCT01118559

Last Updated: 2010-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-01-31

Brief Summary

This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male adult subjects.

Detailed Description

To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.

Conditions

Healthy; Pharmacokinetics of YM150

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

fast-fed sequence group

drug is administered in a fasted condition first, and fed-condition study follows

Group Type: EXPERIMENTAL

YM150

Intervention Type: DRUG

oral

fed-fast sequence group

drug is administered in a fed condition first, and fasted-condition study follows

Group Type: EXPERIMENTAL

YM150

Intervention Type: DRUG

oral

Interventions

YM150

oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body weight: ≥50.0 kg, <80.0 kg
• BMI: ≥17.6, <26.4
• Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests

Exclusion Criteria

• Received any investigational drugs within 120 days before the study
• 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 study
• Received medication within 7 days before the study
• A deviation from the assessment criteria of physical examinations or laboratory tests
• A deviation from the normal reference range of coagulation test [PT or aPTT]
• History of drug allergies
• Upper gastrointestinal disease within 7 days before the study
• Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
• Concurrent or previous malignant tumor
• Previous treatment with YM150

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Astellas Pharma, Inc

Principal Investigators

Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

Kyushu, , Japan

Countries

Japan

Other Identifiers

150-CL-019

Identifier Type: -

Identifier Source: org_study_id