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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00710047

Enrollment

Registered

2008-07-03

Start date

2008-06-30

Completion date

2008-08-31

Last updated

2010-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

ZD4054, Zibotentan, Healthy Volunteers

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)

Interventions

DRUGZD4054

one single 10mg dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
PK variables	frequent sampling occasions during study days

Secondary

Measure	Time frame
Safety variables (adverse events, blood pressure, pulse, safety lab)	During the whole treatment period

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026