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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD5213 (dose escalating) |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5213 | Drug | oral solution, multiple ascending doses |
| |
| Placebo to AZD5213 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, vital signs, physical (including neurological) examinations, clinical laboratory variables, electrocardiograms, telemetry, sleep diary (temporal and qualitative aspects), and the Columbia-Suicide Severity Rating Scale | Up to 30 days screening period. Residential period will be 14 days. Follow up period will be 7 to 10 days after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple-dose PK and dose proportionality | Frequent timepoints within 48 hours of multiple dose day 1 and day 12. | |
| Time to reach steady state | Frequent timepoints within 48 hours of multiple dose day 1 and day 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mathews, MD | Quintiles, 6700 W. 115th Street, Overland Park, KS 66211 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| Label | URL |
|---|---|
| D3030C00002 Clinical Study Report Synopsis | View source |
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| Drug |
|
| Degree of accumulation and time dependancy of orally-administered AZD5213 | Frequent timepoints within 48 hours of multiple dose day 1 and day 12. |