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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00710047
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : November 15, 2010
Information provided by:

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)

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ZD4054 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomised, Open-label, Single-centre, Crossover Study in Healthy Male Volunteers to Assess the Effect of Food on the Pharmacokinetics of a 10 mg Single Oral Dose of ZD4054 (Zibotentan)
Study Start Date : June 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Experimental: 1
Fasting state
Drug: ZD4054
one single 10mg dose
Other Name: Zibotentan

Experimental: 2
after high-fat breakfast
Drug: ZD4054
one single 10mg dose
Other Name: Zibotentan

Primary Outcome Measures :
  1. PK variables [ Time Frame: frequent sampling occasions during study days ]

Secondary Outcome Measures :
  1. Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00710047

United Kingdom
Research Site
Harrow, United Kingdom
Sponsors and Collaborators
Study Director: Thomas Morris AstraZeneca, Medical Science Director
Principal Investigator: David Wessels Parexel

Responsible Party: Thomas Morris, BSc MB BCh MRCP FFPM, Medical Science Director, ZD4054, AstraZeneca R&D Alderely Park Identifier: NCT00710047     History of Changes
Other Study ID Numbers: D4320C00028
ZD4054EudraCt 2008-002744-42
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: November 15, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Healthy Volunteers