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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00709553 |
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Date of registration:
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01/07/2008 |
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Primary sponsor: |
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Public title:
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Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)
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Scientific title:
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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 |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00709553 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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Germany
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Contacts
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Name:
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Thomas Morris |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca, Medical Science Director |
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Name:
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Dago Mazur |
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Address:
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Telephone:
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Email:
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Affiliation:
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PAREXEL International GmbH |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: midazolam
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Drug: ZD4054
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Primary Outcome(s)
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PK variables
[Time Frame: Frequent sampling occasions during study]
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Secondary Outcome(s)
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Safety variables (adverse events, ECG, blood pressure, pulse, safety lab)
[Time Frame: During the whole treatment period]
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Secondary ID(s)
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D4320C00010
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ZD4054EudraCt 2008-002764-35
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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