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This is an open-label, randomized, 3-period crossover, single dose study. Three (3) single doses of AZD3293 (2 different tablet formulations, and an oral solution) will be administered with a washout period of at least 1 week between the doses to investigate the relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution and to evaluate basic systemic pharmacokinetic parameters of the tablet formulations compared to the oral solution of AZD3293.
The safety and tolerability of AZD3293 in healthy subjects will also be assessed in the study. AZD3293 is being developed for the treatment of Alzheimer's disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3293 oral solution | Experimental | single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) |
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| AZD3293 tablet formulation A | Experimental | single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) |
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| AZD3293 tablet formulation B | Experimental | single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3293 oral solution | Drug | Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and solution as a single dose on Day 1, Day 8 or Day 15. |
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| Measure | Description | Time Frame |
|---|---|---|
| The relative bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral solution by assessment of the area under the plasma concentration-time curve from zero to infinity for the tablet formulations and the oral solutio | Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 & 15 and analyzed according to fully validated methods. | up to day 18 (Day 1 - 72 hrs post-dose on Day 15) |
| To compare the tablet formulations of AZD3293 with the oral solution of AZD3293 by evaluation of the basic pharmacokinetic parameters for each formulation | Blood samples for determination of plasma concentrations of AZD3293 and its active metabolite will be collected at pre-dose (15 or 30 min) and 30 min, 1h, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours post-dose starting on Days 1, 8 & 15 and analyzed according to fully validated methods. | up to day 18 (Day 1 - 72 hrs post-dose on Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile in terms of Adverse events assessment | From Baseline and up to day 25 | |
| Safety and tolerability in terms of lab tests assessment (hematology, chemistry, urinalysis) | From Baseline and up to day 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cypress | California | United States |
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| AZD3293 tablet formulation A | Drug | Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8, or Day 15. |
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| AZD3293 tablet formulation B | Drug | Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8 or Day 15. |
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| Safety and tolerability in terms of vital signs assessment (blood pressure, pulse and body temperature) and physical exams | From baseline and up to day 25 |
| Safety and tolerability by assessing changes in electrocardiogram (ECG) parameters | from baseline and up until day 25 |
| ID | Term |
|---|---|
| C000608388 | lanabecestat |
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