Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)
- Registration Number
- NCT00709553
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 midazolam midazolam, one single dose of 705mg 2 ZD4054 ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 ) 2 midazolam ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 )
- Primary Outcome Measures
Name Time Method PK variables Frequent sampling occasions during study
- Secondary Outcome Measures
Name Time Method Safety variables (adverse events, ECG, blood pressure, pulse, safety lab) During the whole treatment period
Trial Locations
- Locations (1)
Research Site
🇩🇪Berlin, Germany