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This is a single centre, double-blind, randomised, parallel group, placebo controlled study to assess the safety, tolerability and pharmacokinetics of AZD1386 when given as multiple doses to 32 (24 healthy young and 8 healthy elderly) Japanese subjects. For young healthy subjects (aged ≥20 to ≤45 inclusive) 3 consecutive multiple ascending dose panels are planned. For elderly healthy subjects (aged ≥65 to≤80 inclusive) 1 multiple dose panel is planned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1386 | Experimental | 4 groups receiving a specified volume of the active component AZD1386 at different points of time. |
|
| Placebo | Placebo Comparator | Included in each dose group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1386 | Drug | Oral admin. of doses at 11 days through a 12 days period. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of AZD1386 after multiple dosing in young and elderly healthy Japanese subjects by assessment of adverse events, vital signs, ECG parameters, body temperature, clinical chemistry, haematology and urinalysis. | All assessments are made at each visit during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the PK profile of AZD1386 after multiple dosing by assessment of plasma concentrations. | Blood samples will be taken before and after study drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Karlsten | Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden | Study Director |
| Shunji Matsuki | Kyusyu Clinical Phramacology Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| 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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| Placebo |
| Drug |
Oral admin. of doses at 11 days through a 12 days period. |
|