Clinical trial NCT05106153: A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem
Official title: A Single-Dose, Double-Blind, Placebo-Controlled, Randomized, Crossover Study to Determine the Abuse Potential of Single Oral Dose of Seltorexant Compared To Suvorexant and Zolpidem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Non-dependent, Recreational Sedative Users
Abuse Potential
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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
* 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

Primary outcomes:
measure: Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)
timeFrame: Up to 24 hour post-dose (up to Day 2)
Secondary outcomes:
measure: Overall Drug Liking VAS (Emax)
timeFrame: 12 hour and 24 hour post-dose
measure: Take Drug Again VAS (Emax)
timeFrame: 12 hour and 24 hour post-dose
measure: Subjective Drug Value (Emax)
timeFrame: 12 hour and 24 hour post-dose
measure: High VAS (Emax)
timeFrame: Pre-dose up to 24 hours post-dose (up to Day 2)
measure: Time to Peak Effect (TEmax) for Drug Liking (At this Moment) VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: Minimum Effect (Emin) for Drug Liking (At this Moment) VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: Time to Minimum Effect (TEmin) for Drug Liking (At this Moment) VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: Time-averaged Area Under the Effects Curve (TA_AUE) for Drug Liking (At This Moment) VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: TEmax of High VAS
timeFrame: Pre-dose up to 24 hours post-dose (up to Day 2)
measure: TA_AUE of High VAS
timeFrame: Pre-dose up to 24 hours post-dose (up to Day 2)
measure: Emax of Good Effect VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: TEmax of Good Effects VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: TA_AUE of Good Effects VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: Emax of Bad Effects VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: TA_AUE of Bad Effects VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: TEmax of Bad Effects VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: Emin of Drowsiness/Alertness VAS
timeFrame: Pre-dose up to 24 hours post-dose (up to Day 2)
measure: TEmin of Drowsiness/Alertness VAS
timeFrame: Pre-dose up to 24 hours post-dose (up to Day 2)
measure: Time-averaged Area Over the Effect Time Curve (TA_AOE) of Drowsiness/Alertness VAS
timeFrame: Pre-dose up to 24 hours post-dose (up to Day 2)
measure: Emin of Relaxation/Agitation VAS
timeFrame: Pre-dose up to 24 hours post-dose (up to Day 2)
measure: TEmin of Relaxation/Agitation VAS
timeFrame: Pre-dose up to 24 hours post-dose (up to Day 2)
measure: TA_AOE of Relaxation/Agitation VAS
timeFrame: Pre-dose up to 24 hours post-dose (up to Day 2)
measure: TEmax of Dizziness VAS
timeFrame: Pre-dose up to 24 hour post-dose (up to Day 2)
measure: Emax of Dizziness VAS
timeFrame: Pre-dose up to 24 hour post-dose (up to Day 2)
measure: TA_AUE of Dizziness VAS
timeFrame: Pre-dose up to 24 hour post-dose (up to Day 2)
measure: Emax of Any Effects VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: TEmax of Any Effects VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: TA_AUE of Any Effects VAS
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: Drug Similarity VAS
timeFrame: 24 hour post-dose
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to Week 20
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 20
measure: Percentage of Participants with Abnormalities in Clinical Laboratory Parameters
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: Percentage of Participants with Abnormalities in Vital Signs
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: Emin of Modified Observer's Assessment of Alertness/Sedation (MOAA/S) of Composite and Sum Score
timeFrame: Up to 24 hour post-dose (up to Day 2)
measure: TA_AOE of MOAA/S of composite and sum score
timeFrame: Up to 24 hour post-dose (up to Day 2)
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Altasciences Inc.
state: Kansas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: