Healthy
Conditions
Brief summary
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.
Interventions
DRUGE2609
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.
DRUGPlacebo
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.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy males and females * Female subjects must be of non-childbearing potential * Aged 50 to 85 years, inclusive BMI of 18 to 32 kg/m2 at screening * Thyroid function tests within normal rangeMini-Mental State Examination score of 28-30, inclusive Key
Exclusion criteria
* History of neurological abnormalities, including seizures * Any clinically significant abnormality of the ECG at Screening and Baseline including QTc prolongation * History of ischemic heart disease, cardiac arrhythmias, cerebrovascular diseases * Other medical conditions that are not stably controlled * Presence of orthostatic hypotension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 19 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 20 days |
| Time at which Amax occurs for plasma Aβ(1-x) | 20 days |
| Plasma Cmax and AUC (0-24h) of E2609 on 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 |
| 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 |
Countries
United States
Outcome results
None listed