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The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446 in young and elderly healthy Japanese volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Oral capsule. Dose single and followed by 5-day repeated dosing. Specific doses depend on panel. |
|
| 2 | Placebo Comparator | Oral capsule. Dose single and followed by 5-day repeated dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1446 | Drug | oral capsule, Moderate Release |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety and tolerability of AZD1446 following single and repeated doses of an orally administered MR capsule of AZD1446 in healthy young and elderly Japanese volunteers by adverse events, vital signs, laboratory variables and ECG. | During the whole study period, ca. 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine PK of AZD1446 following single and repeated doses of AZD1446 MR capsule in healthy young and elderly Japanese volunteers. | PK samplings are taken at defined timepoints during residential period, 10 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Björn Paulsson | AstraZeneca R&D Södertälje | Study Director |
| Shunji Matsuki, PhD | Kyushu Clinical Pharmacology Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Fukuoka | Japan |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C578484 | 3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane |
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| Drug |
oral capsule |
|