Effect of Food Intake on Pharmacokinetic Profiles of Z-338

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00920998
First received: June 15, 2009
Last updated: July 16, 2009
Last verified: July 2009
  Purpose

To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.


Condition Intervention Phase
Healthy
Drug: Z-338
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Pharmacokinetics Study to Evaluate the Effect of Food Intake on PK Profile of Z-338 in Healthy Volunteers

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetics of Z-338 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Z-338
3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)
Drug: Z-338
oral
Other Name: YM443

Detailed Description:

The purpose of the study is to evaluate the influence of food intake on the pharmacokinetic profiles of Z-338 in healthy volunteers by a 3-way cross-over method.

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subject
  • Body weight: 50.0 - 80.0 kg
  • BMI: 17.6 - 26.4

Exclusion Criteria:

  • Receiving an investigational new drug within 120 days of the study
  • Receiving medical treatment drugs within 7 days of the study
  • Blood donation before the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920998

Locations
Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00920998     History of Changes
Other Study ID Numbers: 443-CL-503
Study First Received: June 15, 2009
Last Updated: July 16, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Z-338
YM443
healthy volunteers

ClinicalTrials.gov processed this record on April 16, 2014