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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No. 2008-008389-10 |
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This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6 multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Part A single and multiple dose and part B fractionated dose |
|
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1446 | Drug | Solution, oral single and multiple dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: to assess the safety and tolerability of AZD1446 following multiple ascending doses of an orally administered solution of AZD1446 in male and non-fertile female, young and elderly Healthy Volunteers, | during the whole study period, ca 50 days | |
| Part B: to assess the safety and tolerability of AZD1446 following administration of an oral solution of AZD1446 as fractionated doses during one day in male and non-fertile female, young and elderly Healthy Volunteers. | during the whole study period, ca 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: To determine the single and multiple dose PK of AZD1446 in male and non-fertile female Healthy Volunteers. | PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B | |
| Part B: To mimic an extended release dosing regimen and determine the fractionated dosing PK of AZD1446 in male and non-fertile Healthy Volunteers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Björn Paulsson, MD, PhD | AstraZeneca | Study Director |
| Marianne Hartford, MD PhD | AstraZeneca Clinical Pharmacology Unit (CPU) Sahlgrenska University Hospital GöteborgSE-413 45 GöteborgSweden | Principal Investigator |
| Ingemar Bylesjo, MD PhD | AstraZeneca Clinical Pharmacology Unit (CPU) C2:84Karolinska University Hospital HuddingeSE-141 86 StockholmSweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gothenburg | Sweden | ||||
| Research Site |
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| ID | Term |
|---|---|
| C578484 | 3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane |
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| Drug |
Placebo |
|
| PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B |
| Stockholm |
| Sweden |