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Completed

NCT Number: NCT00710047

Food Effect Study of a Single 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)

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Harrow, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZD4054

Drug

one single 10mg dose

Other names: Zibotentan

Primary outcomes

  1. PK variables

    Time frame: frequent sampling occasions during study days

Secondary outcomes

  1. Safety variables (adverse events, blood pressure, pulse, safety lab)

    Time frame: During the whole treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 3, 2008
Registry last updated
Nov 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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