NCT02583451

Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects

A Randomized, Double-Blind, Placebo- and Active-Controlled, 4-Period Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance

Detailed description

The study will have 2 phases, Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods that will last up to a maximum of 21 days: Screening and Baseline. The Randomization Phase will comprise of four, 9-day treatment periods (Treatment Period 1 - Treatment Period 4) with a minimum 14-day washout between treatment periods, and a follow-up interval of at least 14 days after Treatment Period 4 before the end-of-study (EOS) visit. Participants will be randomized to 1 of 12 sequences in an incomplete blocks design.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Placebo tablet matching lemborexant	Tablet form taken orally at bedtime.
DRUG	Placebo tablet matching zopiclone	Tablet form taken orally at bedtime.
DRUG	Zopiclone 7.5 mg	7.5 mg tablet taken orally at bedtime.
DRUG	Lemborexant 2.5 mg	2.5 tablet taken orally at bedtime.
DRUG	Lemborexant 5 mg	5 mg tablet taken orally at bedtime.
DRUG	Lemborexant 10 mg	10 mg tablet taken orally at bedtime.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-01-31
• Completion: 2017-02-01
• First posted: 2015-10-22
• Last updated: 2018-09-06

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study