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

Phase 1

Completed

• Conditions: Healthy; Pharmacokinetics of YM150
• Interventions: Drug: YM150

• Registration Number: NCT01118559
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-05
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-05
• Last Update Submitted: 2010-05-05
• Study First Posted: 2010-05-06
• Last Update Posted: 2010-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fast-fed sequence group	YM150	drug is administered in a fasted condition first, and fed-condition study follows
fed-fast sequence group	YM150	drug is administered in a fed condition first, and fasted-condition study follows

Primary Outcome Measures

Name	Time	Method
Plasma concentration of YM150 and its metabolites	for 3 days after drug administration

Secondary Outcome Measures

Name	Time	Method
Safety assessed by AEs, vital signs, 12-lead ECG and lab tests	for 3 days after drug administration
PT (prothrombin time)	for 3 days after drug administration
aPTT (activated partial thromboplastin time)	for 2 days after drug administration
FXa (factor Xa) activity	for 1 days after drug administration