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Completed

NCT Number: NCT01118559

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.

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Key information

Conditions

Healthy Pharmacokinetics of YM150

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyushu, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YM150

Drug

oral

Primary outcomes

  1. Plasma concentration of YM150 and its metabolites

    Time frame: for 3 days after drug administration

Secondary outcomes

  1. Safety assessed by AEs, vital signs, 12-lead ECG and lab tests

    Time frame: for 3 days after drug administration

  2. PT (prothrombin time)

    Time frame: for 3 days after drug administration

  3. aPTT (activated partial thromboplastin time)

    Time frame: for 2 days after drug administration

  4. FXa (factor Xa) activity

    Time frame: for 1 days after drug administration

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 6, 2010
Registry last updated
May 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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