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

NCT01118559 | Completed Phase 1

• 1 other identifier: 150-CL-019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Pharmacokinetics of YM150

Keywords

YM150; Food effect; Healthy volunteer

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of YM150 and its metabolites

  for 3 days after drug administration

Secondary Outcomes (4)

• 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

Study Arms (2)

fast-fed sequence group

EXPERIMENTAL

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

Drug: YM150

fed-fast sequence group

EXPERIMENTAL

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

Drug: YM150

Interventions

YM150 DRUG

oral

fast-fed sequence group; fed-fast sequence group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kyushu, Japan

Location

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 6, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 6, 2010

Record last verified: 2010-05

Locations

JP (1)