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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No.2009-013390-18 |
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This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two doses of AZD1446 or placebo in subjects when given for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1446 Low | Experimental | Low dose of AZD1446 |
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| AZD1446 High | Experimental | High dose of AZD1446 |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1446 | Drug | Solution, oral, for 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure). | During the whole study period, Study days 1-68 (30 days of enrolment , study day 1-28 and follow up visit study days 35-38). |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the PK of AZD1446 dosed for 4 weeks in healthy elderly male and female volunteers. PK parameters include renal clearance, AUC (0-24)ss and T1/2 eff. | PK sampling taken at defined timepoints during the treatment period (study days 1-28) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Fransson, MD, PhD | AstraZeneca R&DClinical Pharmacology Unit CPUTunavägen 22aS-221 87 LundSweden | Principal Investigator |
| Björn Paulsson, MD, PhD | AstraZeneca R&D SödertäljeSE-151 85 SödertäljeSweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research | Lund | Sweden |
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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 |
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