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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014