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

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy; Pharmacokinetics of YM150

Treatments: Drug: YM150

Study type: Interventional

Funder types: Industry

Identifiers

NCT01118559

150-CL-019

Details and patient eligibility

About

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

Trial design

24 participants in 2 patient groups

fast-fed sequence group

Experimental group

Description:

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

Treatment:

Drug: YM150

fed-fast sequence group

Experimental group

Description:

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

Treatment:

Drug: YM150