drugset / Trial / NCT03483636

Study of Lemborexant-Alcohol Interaction in Healthy Subjects

NCT03483636

Phase 1 Completed 24 enrolled Eisai Inc. Purdue Pharma LP · collab
RandomizedCrossoverQuadruple-blindBasic science

Summary

This study will be conducted to evaluate the effects on cognitive performance (Power of Attention domain) and postural stability of lemborexant in combination with alcohol versus lemborexant alone and versus alcohol alone in healthy participants. This study will also assess the safety and tolerability of a single oral dose of lemborexant when administered alone or in combination with alcohol in healthy participants.

Timeline

Start
2018-03-12
Primary completion
2018-09-12
Completion
2018-09-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Alcohol Other / unclassified 0.6 g/kg
Subject Alcohol Other / unclassified 0.7 g/kg
Subject Lemborexant Small molecule 10 mg Oral

Indications

No indication recorded.