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| ID | Type | Description | Link |
|---|---|---|---|
| EudractCT: 2008-006552-22 |
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The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1386 | Drug | 1 dose of oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386 | Until >90% of predicted total radioactivity has been recovered | |
| Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta | Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h |
| Measure | Description | Time Frame |
|---|---|---|
| AZD1386 metabolites in plasma+excreta if feasable | Predose, 1h, 4h, 8h 24h | |
| Safety + tolerability of AZD1386 | Predose, 2h, 6h, 12h, 24h, 48h, 168h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raj Chetty, MD | AstraZeneca R&D, CPU Alderley Park, UK | Principal Investigator |
| Lars Ståhle, MD | AstraZeneca R&D, Södertälje, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Macclesfield | CHESHIRE | United Kingdom |
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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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| ID | Term |
|---|---|
| C574562 | AZD1386 |
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