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| ID | Type | Description | Link |
|---|---|---|---|
| EudractCT 2007-005524-33 |
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The purpose of this study is to investigate the safety and tolerability of AZD2066 using multiple escalating dose panels. There will be separate panels for young healthy volunteers and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly receive AZD2066 or placebo. One panel will be run at a time with a fixed dose given. After the completion of each panel, a Safety Review Committee will decide if the study can proceed to the next dose panel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Oral solution. |
|
| 2 | Placebo Comparator | Oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2066 | Drug | Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD2066 by assessment of 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 15 and follow up visit 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD2066 by assessment of adverse events | Non serious adverse events will be collected from the start of Visit 2 until the end of the study. Serious adverse events will be collected from signing of consent until end of study. | |
| Investigate PK profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 (and possible relevant metabolites). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Fransson, MD | AstraZeneca R&D SödertäljeMedical Science, CPU C2:84Karolinska University Hospital HuddingeSE-141 86 Stockholm, Sweden | Principal Investigator |
| Lars Stahle, MD, PhD | AstraZeneca R&D Södertälje Medical Science S-151 85 Södertälje Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stockholm | Sweden |
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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 |
|---|---|
| C587779 | AZD2066 |
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| Placebo | Drug | Administered orally as a solution once per day on day 1, and then day 3 through to day 12. |
|
| PK sampling taken at defined timepoints during residential period and follow-up. |
| Investigate CNS effects of AZD2066 | Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes. |