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This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dose level A, B, C and optional Dose level D and E: single administration and one to three times daily for 6 days (Japanese n=8) |
|
| 2 | Placebo Comparator | placebo given (2 subjects in each dose group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9742 | Drug | IV Formulation |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry) | collected prior to treatment, during treatment and follow-up for a total of 18-22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the Pharmacokinetics of AZD9742 in blood and urine | PK-sampling during 14 pre-defined study days for PK profiling |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Yen, M..D. | California Clinical Trials | Principal Investigator |
| David Melnick | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | United States |
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| Drug |
IV Formulation |
|