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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017702-36 | EudraCT Number |
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Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different Extended/modified-release formulations and one immediate release formulation of AZD1446. In addition the food effect on AZD1446 pharmacokinetics will be investigated.
Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in elderly healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (2 arms) | Experimental | Period 1: randomized to either fasting IR or ER1. Period 2: Cross-over to either IR or ER1. Period 3: ER1 in fed conditions. |
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| Cohort 2 (2 arms) | Experimental | Period 1: randomized to either fasting IR or ER2. Period 2: Cross-over to either IR or ER2. Period 3: ER2 in fed conditions. |
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| Cohort 3( 2 arms) | Experimental | Period 1: randomized to either fasting IR or ER3. Period 2: Cross-over to either IR or ER3. Period 3: ER3 in fed conditions. |
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| Cohort 4 (2 arms) | Experimental | Period 1: randomized to either fasting IR or MR4. Period 2: Cross-over to either IR or MR4. Period 3: MR4 in fed conditions. |
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| Part 2: Extended/Modified release | Experimental | Extended/Modified release capsule to be determined |
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| Part 2: Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1446 | Drug | ER Fast, 90mg, p.o. capsule |
| |
| AZD1446 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F | Part 1 - 11 days | |
| Part 2 Multiple Dose Administration: - Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F Day 9 of Part 2 following multiple dosing in addition to the above • Cmin, tmin, Cavg, fluctuation ratio, RCmax, RAUC(0-τ) | Part 2 - 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Safety and tolerabilty :- Laboratory safety data, vital signs, electrocardiogram, Columbia-Suicide Severity Rating Scale, adverse events, Mini-international neuropsychiatric interview | throughout the approx 7 weeks of study duration | |
| Part 1: Single Dose Administration :• Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lena Bolin | AstraZeneca R&D | Study Director |
| Aslak Rautio | Quintiles Hermelinen AB | Principal Investigator |
| Wolfgang Kühn | Quintiles AB, Phase I Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Luleå | 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 |
ER Moderate, 90mg, p.o. capsule |
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| AZD1446 | Drug | ER Slow, 90mg, p.o. capsule |
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| AZD1446 | Drug | MR |
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| AZD1446 | Drug | IR, 90 mg p.o. capsule |
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| Placebo | Drug | IR |
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| Placebo | Drug | ER/MR |
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| Part 1 - 11 days |
| Part 2 Multiple Dose Administration :- Cmax, tmax, t½λz, AUC0-t, AUC, AUC0-τ (Part 2 only), Frel (Part 1 only), CL/F, Vz/F Day 9 of Part 2 following multiple dosing in addition to the above • Cmin, tmin, Cavg, fluctuation ratio, RCmax, RAUC(0-τ | Part 2 - 10 days |
| Uppsala |
| Sweden |