Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-center, randomized, double-blind, placebo-controlled, sequential, multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening dosing).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo comparator | Placebo Comparator |
| |
| E2006 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2006 | Drug | Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events (AEs) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of E2006 | Part A up to 288 hours postdose; Part B: up to 324 hours postdose |
Not provided
Included:
Excluded:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dohwa Kim | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel, California Clinical Trials | Culver City | California | 90232 | United States | ||
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo comparator |
| Drug |
E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules |
|
| Glendale |
| California |
| 91206 |
| United States |
| D001523 |
| Mental Disorders |