NCT03483636

Study of Lemborexant-Alcohol Interaction in Healthy Subjects

Single-Center, Double-Blind, Placebo-Controlled, Single-Dose, 4-Period Crossover, Drug-Alcohol Interaction Study in Lemborexant in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Lemborexant	Film-coated oral tablet
DRUG	Alcohol	0.6 g/kg (female) or 0.7 g/kg (male) of 40% ethanol (volume per volume) vodka diluted in a low-calorie beverage (e.g., cranberry beverage), for a total volume of 300 mL (approximately 150 mL per aliquot).
DRUG	Placebo	Film-coated oral tablet

Timeline

• Start date: 2018-03-12
• Primary completion: 2018-09-12
• Completion: 2018-09-12
• First posted: 2018-03-30
• Last updated: 2018-10-17

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study