Status:
COMPLETED
Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to to assess the effect of multiple oral doses of ZD4054 (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male subjects.
Eligibility Criteria
Inclusion
- BMI between 18 and 30 kg/m2
- Medical and surgical history and physical examination without any clinically significant findings
- Normal resting ECG with QTcB interval \<450ms
Exclusion
- Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
- Healthy volunteer has a known hypersensitivity to midazolam or any of the excipients of the midazolam tablet
- Medical diagnosis of migraine with an attack during the 12 months prior to Screening
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00709553
Start Date
July 1 2008
End Date
August 1 2008
Last Update
September 28 2010
Active Locations (1)
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1
Research Site
Berlin, Germany