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

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Pharmacokinetics of YM150

Treatments

Drug: YM150

Study type

Interventional

Funder types

Industry

Identifiers

NCT01125670

150-CL-047

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

Male

Ages

20 to 44 years old

Volunteers

Accepts Healthy Volunteers

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 (INR) 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