drugset / Trial / NCT03158025

A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users

NCT03158025

Phase 1 Completed 39 enrolled Eisai Inc. Purdue Pharma LP · collab
RandomizedCrossoverQuadruple-blindTreatment

Summary

The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006) in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and suvorexant) with similar indications (zolpidem and suvorexant) or mechanisms of action (suvorexant).

Timeline

Start
2017-04-19
Primary completion
2018-07-04
Completion
2018-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Lemborexant Small molecule 10 mg Oral
Subject Lemborexant Small molecule 20 mg Oral
Subject Lemborexant Small molecule 30 mg Oral
Subject Suvorexant Small molecule 40 mg Oral
Subject Zolpidem Small molecule 30 mg Oral

Indications