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A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users

NCT03158025 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-06-29

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006) in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and suvorexant) with similar indications (zolpidem and suvorexant) or mechanisms of action (suvorexant).

Conditions

  • Insomnia Disorders

Interventions

DRUG

Zolpidem tablets

Zolpidem 3 x 10 mg tablets will be administered orally.

DRUG

Suvorexant tablets, over-encapsulated

Suvorexant 2 x 20 mg tablets, over-encapsulated, will be administered orally.

DRUG

Lemborexant tablets

Lemborexant 1 x 10 mg, 2 x 10 mg, or 3 x 10 mg tablets will be administered orally.

DRUG

Placebo lemborexant

Placebo 1 x 10 mg, 2 x 10 mg, or 3 x 10 mg lemborexant tablets will be administered orally.

DRUG

Placebo zolpidem

Placebo 3 x 10 mg zolpidem tablets will be administered orally.

DRUG

Placebo suvorexant

Placebo 2 x 20 mg suvorexant tablets, over-encapsulated, will be administered orally.

Sponsors & Collaborators

  • Purdue Pharma LP

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-19
Primary Completion
2018-07-04
Completion
2018-07-04
FDA Drug
Yes

Countries

  • Canada

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 NCT03158025 on ClinicalTrials.gov