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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00710047
First Posted: July 3, 2008
Last Update Posted: November 15, 2010
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.
Information provided by:
AstraZeneca
July 1, 2008
July 3, 2008
November 15, 2010
June 2008
August 2008   (Final data collection date for primary outcome measure)
PK variables [ Time Frame: frequent sampling occasions during study days ]
Same as current
Complete list of historical versions of study NCT00710047 on ClinicalTrials.gov Archive Site
Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]
Same as current
Not Provided
Not Provided
 
Food Effect Study of a Single Dose of ZD4054 (Zibotentan)
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)
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)
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Volunteers
Drug: ZD4054
one single 10mg dose
Other Name: Zibotentan
  • Experimental: 1
    Fasting state
    Intervention: Drug: ZD4054
  • Experimental: 2
    after high-fat breakfast
    Intervention: Drug: ZD4054
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00710047
D4320C00028
ZD4054EudraCt 2008-002744-42
No
Not Provided
Not Provided
Thomas Morris, BSc MB BCh MRCP FFPM, Medical Science Director, ZD4054, AstraZeneca R&D Alderely Park
AstraZeneca
Not Provided
Study Director: Thomas Morris AstraZeneca, Medical Science Director
Principal Investigator: David Wessels Parexel
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP