Drug Interaction study to asses multiple doses of ZD4054 (Zibotentan)
Study identifier:D4320C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Open-label, Crossover, Phase I Study to Assess the Effect of Multiple Oral Doses of ZD4054 (Zibotentan) on the Pharmacokinetics of a CYP450 3A Probe (midazolam) in Healthy Male Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
midazolam, ZD4054
Sex
Male
Actual Enrollment
12
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Jul 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 midazolam, one single dose of 705mg | - |
| Experimental: 2 ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 ) | Drug: ZD4054 ZD4054 10 mg od Other Name: Zibotentan |
Contacts
Investigators
Principal Investigator
Thomas Morris
AstraZeneca, Medical Science Director
