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drugset / Trial / NCT01673451

2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects

NCT01673451 ↗

Phase 1 Completed 24 enrolled Eisai Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

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).

Timeline

Start
2012-08
Primary completion
2013-05
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Lemborexant Small molecule 2.5 mg Oral
Subject Lemborexant Small molecule 5 mg Oral
Subject Lemborexant Small molecule 10 mg Oral
Subject Lemborexant Small molecule 25 mg Oral
Subject Lemborexant Small molecule 50 mg Oral
Subject Lemborexant Small molecule 75 mg Oral

Indications

central nervous system disorder