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| ID | Type | Description | Link |
|---|---|---|---|
| ZD4054EudraCt 2008-002764-35 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | midazolam, one single dose of 705mg |
|
| 2 | Experimental | ZD4054(Zibotentan)- 10mg od, 7 days + midazolam (one single dose of 7.5 mg on day 6 ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam | Drug |
|
| |
| ZD4054 |
| Measure | Description | Time Frame |
|---|---|---|
| PK variables | Frequent sampling occasions during study |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (adverse events, ECG, blood pressure, pulse, safety lab) | During the whole treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Morris | AstraZeneca, Medical Science Director | Study Director |
| Dago Mazur | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20678684 | Derived | Tomkinson HK, Kemp JV, Wollseifen T, Morris T, Oliver SD. An open-label, randomized, single-center, two-period, phase I, crossover study of the effect of zibotentan (ZD4054) on the pharmacokinetics of midazolam in healthy male volunteers. Clin Ther. 2010 Jul;32(7):1372-86. doi: 10.1016/j.clinthera.2010.07.013. |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| C511404 | ZD4054 |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
ZD4054 10 mg od |
|
|
| D006571 | Heterocyclic Compounds |