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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118559
• Other study ID #: 150-CL-019
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2010
• Last updated: May 5, 2010
• Start date: November 2009
• Est. completion date: January 2010

Study information

• Verified date: May 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy
• Pharmacokinetics of YM150

Intervention

Drug:
• YM150
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of YM150 and its metabolites		for 3 days after drug administration	No
Secondary	Safety assessed by AEs, vital signs, 12-lead ECG and lab tests		for 3 days after drug administration	No
Secondary	PT (prothrombin time)		for 3 days after drug administration	No
Secondary	aPTT (activated partial thromboplastin time)		for 2 days after drug administration	No
Secondary	FXa (factor Xa) activity		for 1 days after drug administration	No