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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 AZD6765 in healthy male and female Japanese and Caucasian subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator | given (2 subjects in each ethnic/dose group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6765 | Drug | single administration and once daily for 5 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments | During the study |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine | During residential period | |
| Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Yen, MD | California Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | United States | |||
| Research Site |
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| Label | URL |
|---|---|
| D6702C00013 Clinical Study Report Synopsis | View source |
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| ID | Term |
|---|---|
| C585977 | AZD6765 |
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| Drug |
single administration and once daily for 5 days |
|
| During the study |
| Baltimore |
| Maryland |
| United States |