Food Effect Study of a Single Dose of ZD4054 (Zibotentan) | NCT00710047

Studies
Food Effect Study of a Single Dose of ZD4054 (Zibotentan)

NCT00710047

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Nov 15, 2010Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

ZD4054

Countries

United Kingdom

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

ID	Type	Description	Link
ZD4054EudraCt 2008-002744-42

Status Module

Record Verification Date

Nov 2010

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

Jun 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jul 1, 2008

First Submission Date that Met QC Criteria

Jul 2, 2008

First Posted Date

Jul 3, 2008Estimated

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

Nov 10, 2010

Last Update Posted Date

Nov 15, 2010Estimated

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

The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg single oral dose of ZD4054 (Zibotentan)

Detailed Description

Not provided

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Fasting state	Drug: ZD4054
2	Experimental	after high-fat breakfast	Drug: ZD4054

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZD4054	Drug	one single 10mg dose	1 2	Zibotentan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PK variables		frequent sampling occasions during study days

Secondary Outcomes

Measure	Description	Time Frame
Safety variables (adverse events, blood pressure, pulse, safety lab)		During the whole treatment period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI between 18 and 30 kg/m2
Medical and surgical history and physical examination without any clinically significant findings
Able to consume standard FDA specified high-fat breakfast.

Exclusion Criteria:

Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
Medical diagnosis of migraine with an attack during the 12 months prior to Screening
Use of prescription medication within 2 weeks before dosing

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Morris	AstraZeneca, Medical Science Director	Study Director
David Wessels	Parexel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Harrow			United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C511404	ZD4054

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided