A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Non-dependent, Recreational Sedative Users, Abuse Potential

In brief

The purpose of this study is to evaluate the abuse potential of seltorexant compared to placebo and two active comparators (zolpidem and suvorexant) in non-dependent, recreational sedative users.

Key facts

Study ID

NCT05106153

Run by

Janssen Research & Development, LLC

People needed

127

Starts

2021-12-17

Expected to finish

2023-05-12

Last updated by the study team

2025-04-27

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Be a current, recreational, not physically dependent, drug user
• Participant must be medically stable
• All female participants must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of the qualification phase and on Day -1 of each treatment period of the treatment Phase
• Blood pressure (after the participant is in a sitting position for 5 minutes) between 90 millimeters of mercury (mmHg) and 160 mmHg systolic, inclusive, and no higher than 100 mmHg diastolic at screening and Day -1 prior to qualification phase randomization
• A 12-lead ECG consistent with normal cardiac conduction and function, including: sinus rhythm, pulse rate between 40 and 100 beats per minute (bpm), QTc interval less than or equal to (<=) 450 milliseconds (ms) for males, <=470 for females, QRS interval of less than (<) 120 ms, PR interval <210 ms, Morphology consistent with healthy cardiac conduction and function

You may not qualify if…

• Known allergies to seltorexant, zolpidem, and suvorexant
• Previous history of recurrent fainting, collapses, syncope, orthostatic hypotension, or vasovagal reactions
• Prescription medications except for stable medical problems such as hypertension, elevated cholesterol, and non-insulin-dependent diabetes mellitus with stable medications for at least 1 month prior to screening
• Participants who have ever been in treatment for substance use disorders (except smoking cessation) or are currently seeking treatment for substance use disorders. In addition, currently seeking or participating in a substance rehabilitation program should be excluded
• Preplanned surgery or procedures that would interfere with the conduct of the study

Where it is running

• Altasciences Inc. — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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