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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00710047
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
2
Duration (Months)
15
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2008
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Fasting state

Drug: ZD4054
one single 10mg dose
Other Names:
  • Zibotentan

    		•
    Experimental: 2

    after high-fat breakfast

    Drug: ZD4054
    one single 10mg dose
    Other Names:
  • Zibotentan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PK variables [frequent sampling occasions during study days]

    Secondary Outcome Measures

    1. Safety variables (adverse events, blood pressure, pulse, safety lab) [During the whole treatment period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Harrow United Kingdom

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Thomas Morris, AstraZeneca, Medical Science Director
    • Principal Investigator: David Wessels, Parexel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00710047
    Other Study ID Numbers:
    • D4320C00028
    • ZD4054EudraCt 2008-002744-42
    First Posted:
    Jul 3, 2008
    Last Update Posted:
    Nov 15, 2010
    Last Verified:
    Nov 1, 2010
    Keywords provided by , ,
    ZD4054
    Zibotentan
    Healthy Volunteers

    Study Results

    No Results Posted as of Nov 15, 2010