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The primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1446 |
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| 2 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1446 | Drug | Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel. |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG. | During the whole study period, ca. 50 days. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine pharmacokinetics(PK) of AZD1446 following single and multiple dosing of AZD1446 in healthy young and elderly Japanese subjects. | PK sampling taken at defined timepoints during residential period, 12 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Björn Paulsson, MD, PhD | AstraZeneca R&D Södertälje | Study Director |
| Shunji Matsuki, MD, PhD | Kyusyu Clinical Phramacology Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan |
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| ID | Term |
|---|---|
| C578484 | 3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane |
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| Placebo | Drug | Oral solution Dose single and followed by 7-day multiple dosing. |
|