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

NCT05106153 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10909942847922MDD1017
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Non-dependent, Recreational Sedative Users; Abuse Potential

Outcome Measures

Primary Outcomes (1)

• Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)

  Emax for drug liking VAS will be reported. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).

  Up to 24 hour post-dose (up to Day 2)

Secondary Outcomes (35)

• Overall Drug Liking VAS (Emax)

  12 hour and 24 hour post-dose

• Take Drug Again VAS (Emax)

  12 hour and 24 hour post-dose

• Subjective Drug Value (Emax)

  12 hour and 24 hour post-dose

• High VAS (Emax)

  Pre-dose up to 24 hours post-dose (up to Day 2)

• Time to Peak Effect (TEmax) for Drug Liking (At this Moment) VAS

  Up to 24 hour post-dose (up to Day 2)

Study Arms (12)

Qualification Phase: Treatment Sequence YXZ

EXPERIMENTAL

Participants will receive a single oral dose of suvorexant (Treatment Y) in qualification period 1, followed by single oral dose of placebo (Treatment X) in qualification period 2 and then single oral dose of zolpidem (Treatment Z) in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Placebo

Qualification Phase: Treatment Sequence ZYX

EXPERIMENTAL

Participants will receive Treatment Z in qualification period 1, followed by Treatment Y in qualification period 2, and then Treatment X in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Placebo

Qualification Phase: Treatment Sequence XZY

EXPERIMENTAL

Participants will receive Treatment X in qualification period 1, followed by Treatment Z in qualification period 2, and then Treatment Y in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Placebo

Qualification Phase: Treatment Sequence YZX

EXPERIMENTAL

Participants will receive Treatment Y in qualification period 1, followed by Treatment Z in qualification period 2, and then Treatment X in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Placebo

Qualification Phase: Treatment Sequence ZXY

EXPERIMENTAL

Participants will receive Treatment Z in qualification period 1, followed by Treatment X in qualification period 2, and then Treatment Y in qualification period 3 on Day 1 during qualification phase. Each treatment will be separated by washout of at least 3 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Placebo

Qualification Phase: Treatment Sequence XYZ

EXPERIMENTAL

Participants will receive Treatment X in qualification period 1, followed by Treatment Y in qualification period 2, and then Treatment Z in qualification period 3 on Day 1 during each qualification phase. Each treatment will be separated by washout of at least 3 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Placebo

Treatment Phase: Treatment Sequence ABFCED

EXPERIMENTAL

Participants will receive a single oral dose of placebo (Treatment A) in treatment period 1, followed by single oral dose of suvorexant (Treatment B) in treatment period 2, single oral Dose 3 of seltorexant (Treatment F) in treatment period 3, single oral dose of zolpidem (Treatment C) in treatment period 4, single oral Dose 2 of seltorexant (Treatment E) in treatment period 5 and then a single oral Dose 1 of seltorexant (Treatment D) in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Seltorexant; Drug: Placebo

Treatment Phase: Treatment Sequence BCADFE

EXPERIMENTAL

Participants will receive Treatment B in treatment period 1, followed by Treatment C in treatment period 2, Treatment A in treatment period 3, Treatment D in treatment period 4, Treatment F in treatment period 5 and then Treatment E in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Seltorexant; Drug: Placebo

Treatment Phase: Treatment Sequence CDBEAF

EXPERIMENTAL

Participants will receive Treatment C in treatment period 1, followed by Treatment D in treatment period 2, Treatment B in treatment period 3, Treatment E in treatment period 4, Treatment A in treatment period 5 and then Treatment F in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Seltorexant; Drug: Placebo

Treatment Phase: Treatment Sequence DECFBA

EXPERIMENTAL

Participants will receive Treatment D in treatment period 1, followed by Treatment E in treatment period 2, Treatment C in treatment period 3, Treatment F in treatment period 4, Treatment B in treatment period 5 and then Treatment A in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Seltorexant; Drug: Placebo

Treatment Phase: Treatment Sequence: EFDACB

EXPERIMENTAL

Participants will receive Treatment E in treatment period 1, followed by Treatment F in treatment period 2, Treatment D in treatment period 3, Treatment A in treatment period 4, Treatment C in treatment period 5 and then Treatment B in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Seltorexant; Drug: Placebo

Treatment Phase: Treatment Sequence FAEBDC

EXPERIMENTAL

Participants will receive Treatment F in treatment period 1, followed by Treatment A in treatment period 2, Treatment E in treatment period 3, Treatment B in treatment period 4, Treatment D in treatment period 5 and Treatment C in treatment period 6 on Day 1 during each treatment phase. Each treatment will be separated by washout of at least 5 days.

Drug: Suvorexant; Drug: Zolpidem; Drug: Seltorexant; Drug: Placebo

Interventions

Suvorexant DRUG

Suvorexant will be administered orally as per assigned treatment sequence.

Qualification Phase: Treatment Sequence XYZ; Qualification Phase: Treatment Sequence XZY; Qualification Phase: Treatment Sequence YXZ; Qualification Phase: Treatment Sequence YZX; Qualification Phase: Treatment Sequence ZXY; Qualification Phase: Treatment Sequence ZYX; Treatment Phase: Treatment Sequence ABFCED; Treatment Phase: Treatment Sequence BCADFE; Treatment Phase: Treatment Sequence CDBEAF; Treatment Phase: Treatment Sequence DECFBA; Treatment Phase: Treatment Sequence FAEBDC; Treatment Phase: Treatment Sequence: EFDACB

Zolpidem DRUG

Zolpidem will be administered orally as per assigned treatment sequence.

Qualification Phase: Treatment Sequence XYZ; Qualification Phase: Treatment Sequence XZY; Qualification Phase: Treatment Sequence YXZ; Qualification Phase: Treatment Sequence YZX; Qualification Phase: Treatment Sequence ZXY; Qualification Phase: Treatment Sequence ZYX; Treatment Phase: Treatment Sequence ABFCED; Treatment Phase: Treatment Sequence BCADFE; Treatment Phase: Treatment Sequence CDBEAF; Treatment Phase: Treatment Sequence DECFBA; Treatment Phase: Treatment Sequence FAEBDC; Treatment Phase: Treatment Sequence: EFDACB

Seltorexant DRUG

Seltorexant will be administered orally as per assigned treatment sequence.

Also known as: JNJ-42847922

Treatment Phase: Treatment Sequence ABFCED; Treatment Phase: Treatment Sequence BCADFE; Treatment Phase: Treatment Sequence CDBEAF; Treatment Phase: Treatment Sequence DECFBA; Treatment Phase: Treatment Sequence FAEBDC; Treatment Phase: Treatment Sequence: EFDACB

Placebo DRUG

Placebo will be administered orally as per assigned treatment sequence.

Qualification Phase: Treatment Sequence XYZ; Qualification Phase: Treatment Sequence XZY; Qualification Phase: Treatment Sequence YXZ; Qualification Phase: Treatment Sequence YZX; Qualification Phase: Treatment Sequence ZXY; Qualification Phase: Treatment Sequence ZYX; Treatment Phase: Treatment Sequence ABFCED; Treatment Phase: Treatment Sequence BCADFE; Treatment Phase: Treatment Sequence CDBEAF; Treatment Phase: Treatment Sequence DECFBA; Treatment Phase: Treatment Sequence FAEBDC; Treatment Phase: Treatment Sequence: EFDACB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Altasciences Inc.

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

suvorexant; Zolpidem; seltorexant

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 3, 2021
• Study Start: December 17, 2021
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)