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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00710047
First received: July 1, 2008
Last updated: November 10, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Healthy Volunteers
 Drug: ZD4054
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK variables [ Time Frame: frequent sampling occasions during study days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710047

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

No publications provided

Responsible Party: Thomas Morris, BSc MB BCh MRCP FFPM, Medical Science Director, ZD4054, AstraZeneca R&D Alderely Park
ClinicalTrials.gov Identifier: NCT00710047     History of Changes
Other Study ID Numbers: D4320C00028, ZD4054EudraCt 2008-002744-42
Study First Received: July 1, 2008
Last Updated: November 10, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
ZD4054
Zibotentan
Healthy Volunteers

ClinicalTrials.gov processed this record on May 16, 2013