Insomnia
Conditions
Brief summary
This is a single-center, open-label, randomized crossover study being conducted in three cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.
Interventions
DRUGE2006
2.5 mg, 10 mg, and 25 mg E2006 tablets
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: * Healthy males or females, * ages 18 to 55 years * Body mass index (BMI) > * 18 and 32 kg/m2 at Screening Exclusion: * Female subjects who are nursing * Subjects with a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profiles of E2006 * Subjects with a known history of clinically significant drug or food allergies * Subjects with a known allergy or hypersensitivity to capsule or tablet ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of E2006 of tablet vs. capsule formulations | up to 336 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | 36 days |
Countries
United States
Outcome results
None listed