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

Conditions

• Abuse Potential
• Healthy Non-dependent, Recreational Sedative Users

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• Suvorexant — DRUG
  Suvorexant will be administered orally as per assigned treatment sequence.
• Zolpidem — DRUG
  Zolpidem will be administered orally as per assigned treatment sequence.
• Seltorexant — DRUG
  Seltorexant will be administered orally as per assigned treatment sequence.
• Placebo — DRUG
  Placebo will be administered orally as per assigned treatment sequence.

Study Details

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 Dates

Start date

Dec 17, 2021

Status verified

Apr 2025

Primary completion

May 12, 2023

Completion

May 12, 2023

Study Design

Enrollment

127 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS) [ Time Frame: Up to 24 hour post-dose (up to Day 2) ]

Locations (1)

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