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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Pharmacokinetics of YM150
• Intervention / Treatment: Drug: YM150

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kyushu, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fast-fed sequence group; drug is administered in a fasted condition first, and fed-condition study follows	Drug: YM150; oral
Experimental: fed-fast sequence group; drug is administered in a fed condition first, and fasted-condition study follows	Drug: YM150; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentration of YM150 and its metabolites	for 3 days after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: May 5, 2010
• First Submitted That Met QC Criteria: May 5, 2010
• First Posted (Estimate): May 6, 2010

Study Record Updates

• Last Update Posted (Estimate): May 6, 2010
• Last Update Submitted That Met QC Criteria: May 5, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Food effect; Healthy volunteer; YM150
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Darexaban
• Other Study ID Numbers: 150-CL-019