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| ID | Type | Description | Link |
|---|---|---|---|
| 4054IL/0025 |
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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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This study is designed to compare how ZD4054 (Zibotentan) is taken up, how it is broken down and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to healthy subjects of a similar age, sex and weight. As for all clinical trials, safety and tolerability of the drug will be evaluated as well to develop dosing recommendations for dosing of ZD4054 (Zibotentan) in subjects with varying stages of hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Control (healthy volunteers) |
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| 2 | Experimental | Mild Hepatic Impairment |
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| 3 | Experimental | Moderate Hepatic Impairment |
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| 4 | Experimental | Severe Hepatic Impairment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD4054 | Drug | 10mg, Oral tablet, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Characterise the pharmacokinetic profile of ZD4054 (Zibotentan) following a single 10 mg oral dose in subjects with normal hepatic function and in subjects with varying degrees of hepatic impairment. | predose and 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety of Zibotentan following a single 10 mg oral dose in subjects with normal hepatic function and in subjects with varying degrees of hepatic impairment by assessment of vital signs, ECG, clinical chemistry, haematology and adverse events. | Predose until post-study medical | |
| Explore changes in protein binding of Zibotentan and the subsequent effects on its pharmacokinetics in subjects with normal hepatic function and in subjects with varying degrees of hepatic impairment by assessment of free Cmax, free AUC and unbound CL/F. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Morris | AstraZeneca, Medical Science Director | Study Director |
| Blanka Cieslarova, MD | Medical Director & Head of Clinical Unit, PRA International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Prague | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21414193 | Derived | Tomkinson H, Kemp J, Oliver S, Swaisland H, Taboada M, Morris T. Pharmacokinetics and tolerability of zibotentan (ZD4054) in subjects with hepatic or renal impairment: two open-label comparative studies. BMC Clin Pharmacol. 2011 Mar 17;11:3. doi: 10.1186/1472-6904-11-3. |
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| ID | Term |
|---|---|
| C511404 | ZD4054 |
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| 3 hour post-dose |