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The purpose of this single-center, randomized, double-blind, placebo-controlled, study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered to healthy elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2609 | Experimental | E2609 at ascending doses |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2609 | Drug | E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Cmax and AUC (0-24h) of E2609 on Day 1 and Day 14 | 20 days | |
| Plasma Aβ(1-x) Amax (defined as maximum change (%) of E2609 levels compared to time-matched baseline at a single time point within 24 hours postdose) in plasma and cerebrospinal fluid, plasma and CSF |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Curtis | Compass Research Phase 1, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Compass Research Phase 1, LLC | Orlando | Florida | 32806 | United States |
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| Placebo | Drug | E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose. |
|
| 20 days |
| Time at which Amax occurs for plasma Aβ(1-x) | 20 days |
| Area under the plasma Aβ(1-x) concentration, AUAC(0-24h), by time curve from time 0 to time 24 hours on Day -1, Day 1, and Day 14 | 20 days |
| Change (%) in plasma Aβ(1-x) AUAC within 24 hours comparing Day 1 to Day -1 and Day 14 to Day -1 | 20 days |
| Percent change of Aβ(1-x) in CSF from Day -2 to Day 14 | 20 days |