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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05106153

42847922MDD1017 (Other Identifier)

CR109099

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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127 participants in 12 patient groups

Qualification Phase: Treatment Sequence YXZ

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Zolpidem

Drug: Suvorexant

Qualification Phase: Treatment Sequence ZYX

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Zolpidem

Drug: Suvorexant

Qualification Phase: Treatment Sequence XZY

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Zolpidem

Drug: Suvorexant

Qualification Phase: Treatment Sequence YZX

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Zolpidem

Drug: Suvorexant

Qualification Phase: Treatment Sequence ZXY

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Zolpidem

Drug: Suvorexant

Qualification Phase: Treatment Sequence XYZ

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Zolpidem

Drug: Suvorexant

Treatment Phase: Treatment Sequence ABFCED

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Seltorexant

Drug: Zolpidem

Drug: Suvorexant

Treatment Phase: Treatment Sequence BCADFE

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Seltorexant

Drug: Zolpidem

Drug: Suvorexant

Treatment Phase: Treatment Sequence CDBEAF

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Seltorexant

Drug: Zolpidem

Drug: Suvorexant

Treatment Phase: Treatment Sequence DECFBA

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Seltorexant

Drug: Zolpidem

Drug: Suvorexant

Treatment Phase: Treatment Sequence: EFDACB

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Seltorexant

Drug: Zolpidem

Drug: Suvorexant

Treatment Phase: Treatment Sequence FAEBDC

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Seltorexant

Drug: Zolpidem

Drug: Suvorexant