Food effect study of a single dose of ZD4054 (Zibotentan)
Study identifier:D4320C00028
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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)
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ZD4054
Sex
Male
Actual Enrollment
30
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Jun 2008
Primary Completion Date: 01 Aug 2008
Study Completion Date: 01 Aug 2008
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Thomas Morris
AstraZeneca, Medical Science Director
