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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ZD4054

Study type: Interventional

Funder types: Industry

Identifiers

NCT00710047

ZD4054EudraCt 2008-002744-42

D4320C00028

Details and patient eligibility

About

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)

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1

Experimental group

Description:

Fasting state

Treatment:

Drug: ZD4054

2

Experimental group

Description:

after high-fat breakfast

Treatment:

Drug: ZD4054