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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014