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The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose to Japanese healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Capsule administered once orally |
|
| 2 | Placebo Comparator | Capsule administered once orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2516 | Drug | Capsule administered once orally. Specific dose depends on dose panel. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG | Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 3 and follow up visit 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects | Blood sampling at defined timepoints during residential period and follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Neijber, 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 |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
Capsule administered once orally |
|