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

• Status: Not yet recruiting
• Trial end date: 2023-03-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Suvorexant; Zolpidem

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Currently seeking or participating in a substance rehabilitation program

• Preplanned surgery or procedures that would interfere with the conduct of the study