Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations

Eisai

Status and phase

Completed

Phase 1

Conditions

Insomnia

Treatments

Drug: E2006

Study type

Interventional

Funder types

Industry

Identifiers

NCT01673880

E2006-A001-005

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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