Effect of Food Intake on Pharmacokinetic Profiles of Z-338

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

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Key information

Conditions

Healthy

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyushu, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Z-338

Drug

oral

Other names: YM443

Primary outcomes

Pharmacokinetics of Z-338

Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Pharmacokinetics Study to Evaluate the Effect of Food Intake on PK Profile of Z-338 in Healthy Volunteers

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jun 16, 2009
Registry last updated: Jul 20, 2009

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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Completed