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Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 160mg oral dose of AZD8931 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8931 | Drug | 160mg oral single dose (4 x 40mg tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the effect of food on the pharmacokinetics of AZD8931 160mg oral dose | Multiple blood PK samples taken between predose to up to 5 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG | Maximus of 7 weeks (From time of consent to last visit including any follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emeline Ramos, MD | AstraZeneca, Clinical Pharamcology Unit, Alderley Park | Principal Investigator |
| Mary Stuart, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Alderley Park | Cheshire | United Kingdom |
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| ID | Term |
|---|---|
| C548875 | AZD 8931 |
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