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| ID | Type | Description | Link |
|---|---|---|---|
| ZD4054IL0017 |
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This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ZD4054 + Moxifloxacin placebo |
|
| 2 | Active Comparator | ZD4054 placebo + Moxifloxacin |
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| 3 | Experimental | ZD4054 + ZD4054 placebo + Moxifloxacin placebo |
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| 4 | Placebo Comparator | ZD4054 Placebo + Moxifloxacin placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD4054 | Drug | ZD4054 10mg Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo | Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h |
| Measure | Description | Time Frame |
|---|---|---|
| assess the maximum of the mean changes in time-matched QT, QTcB (Bazett's correction), QTcF (Fridericia's correction) and QTcI (subject specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo | Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h | |
| assess the maximum of mean changes in time-matched QTcX, QT, QTcB, QTcF and QTcI intervals after moxifloxacin administration compared to placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raj Chetty, MD | Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Macclesfield | United Kingdom |
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| Moxifloxacin | Drug | 400 mg capsule |
|
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| ZD4054 Placebo | Drug | 3 tablets |
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| Moxifloxacin placebo | Drug | 1 capsule |
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| ZD4054 Placebo | Drug | 2 tablets |
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| ZD4054 | Drug | 30mg tablet |
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| ZD4054 | Drug | 10mg tablet |
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| Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h |
| further assess the safety and tolerability of ZD4054 (Zibotentan) by assessment of adverse events (AEs), laboratory variables and vital signs. | From time of Consent to Last Follow-up Visit |
| ID | Term |
|---|---|
| C511404 | ZD4054 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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