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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009940-22 |
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This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8529 | Drug | Oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis. | From screening period to follow-up, 42 days (maiximum). |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics of AZD8529 in plasma and urine. | Blood and urine sampling from pre-dose until 12 days post dose. | |
| To collect and store DNA for future exploratory research | One blood sampling after randomisation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Lorch, MD MFPM FRCA | Richmond Pharmacology Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| ID | Term |
|---|---|
| C000608263 | AZD8529 |
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| Drug |
Oral |
|