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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ZD4054

• Registration Number: NCT00710047
• Lead Sponsor: AstraZeneca

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-10
• Last Update Posted: 2010-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	ZD4054	after high-fat breakfast
1	ZD4054	Fasting state

Primary Outcome Measures

Name	Time	Method
PK variables	frequent sampling occasions during study days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Harrow, United Kingdom