Effect of Food Intake on Pharmacokinetic Profiles of Z-338 | NCT00920998

Studies
Effect of Food Intake on Pharmacokinetic Profiles of Z-338

NCT00920998

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jul 20, 2009Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Z-338

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Jun 15, 2009

First Submission Date that Met QC Criteria

Jun 15, 2009

First Posted Date

Jun 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2009

Last Update Posted Date

Jul 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. Z-338	Experimental	3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)	Drug: Z-338

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Z-338	Drug	oral	1. Z-338	YM443

Measure	Description	Time Frame
Pharmacokinetics of Z-338		48 hours

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

Intervention Browse Module

MeSH Terms

ID	Term
C410959	Z 338

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided