drugset / Trial / NCT02039089

A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects

NCT02039089

Phase 1 Completed 32 enrolled Eisai Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will be a single-center, multiple-dose, randomized, double-blind, placebo-controlled, parallel-group study in healthy male and female subjects. The study will consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and Part B (one cohort of healthy white subjects dosed in the evening). The cohorts will be conducted sequentially. Part A will be started first with the 2.5-mg dose cohort, followed by the 10-mg dose cohort and then the 25-mg dose cohort. Part B will be conducted in parallel with the 10-mg cohort of Part A, with the possibility of overlap.

Timeline

Start
2014-01
Primary completion
2014-05
Completion
2014-05

Drugs

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

Indications

No indication recorded.