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

PHASE1CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

April 19, 2017

Primary Completion Date

July 4, 2018

Study Completion Date

July 4, 2018

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.

Trial Locations (1)

M5V 2T3

INC Research Toronto, Inc., Toronto

All Listed Sponsors
collaborator

Purdue Pharma LP

INDUSTRY

lead

Eisai Inc.

INDUSTRY

NCT03158025 - 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 | Biotech Hunter | Biotech Hunter