drugset / Trial / NCT01673880

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

NCT01673880

Phase 1 Completed 40 enrolled Eisai Inc.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2012-08
Primary completion
2012-10
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lemborexant Small molecule 2.5 mg
Subject Lemborexant Small molecule 10 mg
Subject Lemborexant Small molecule 25 mg

Indications