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

NCT02583451 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-09-06

No results posted yet for this study

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

Conditions

  • Healthy Participants

Interventions

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.

Sponsors & Collaborators

  • Purdue Pharma LP

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-01-31
Completion
2017-02-28
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583451 on ClinicalTrials.gov