NCT03008447

Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older

A Randomized, Double-Blind, Placebo-Controlled and Active Comparator, 4 Period Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose administration at bedtime.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	LEM5	Single dose of lemborexant 5 mg administered within 5 minutes before bedtime.
DRUG	LEM10	Single dose of lemborexant 10 mg administered within 5 minutes before bedtime.
DRUG	ZOL	Single dose of zolpidem 6.25 mg administered within 5 minutes before bedtime.
DRUG	PBO	Single dose of placebo administered within 5 minutes before bedtime.

Timeline

• Start date: 2016-11-21
• Primary completion: 2018-01-03
• Completion: 2018-01-03
• First posted: 2017-01-02
• Last updated: 2019-08-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study