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The aim of the study is to compare how different formulations of AZD0530 are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0530 | Drug | of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation. | Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples. |
| Measure | Description | Time Frame |
|---|---|---|
| To monitor the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events. | From time of consent to last visit. | |
| An exploratory objective is to characterise the Pharmacokinetic profile of an oral solution of AZD0530 and 4 additional tablet variants of the Phase III formulation of AZD0530 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raj Chetty, MD | AstraZeneca, Clinical Pharmacology Unit, Alderley Park | Principal Investigator |
| Mary Stuart, MD | AstraZeneca,Parklands, Alderley Park | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Alderley Park | United Kingdom |
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| ID | Term |
|---|---|
| C515233 | saracatinib |
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| AZD0530 | Drug | Part II: Single doses of AZD0530 125mg oral solution and 2 out of 4 125mg tablet variants (C, D, E and F) in a random order. |
|
| Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples. |