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

Janssen Research & Development, LLC127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

127

Conditions

Healthy Non-dependent, Recreational Sedative Users Abuse Potential

Interventions

SuvorexantDRUG

Suvorexant will be administered orally as per assigned treatment sequence.

ZolpidemDRUG

Zolpidem will be administered orally as per assigned treatment sequence.

SeltorexantDRUG

Seltorexant will be administered orally as per assigned treatment sequence.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Altasciences Inc.

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

Overall Drug Liking VAS (Emax)

Emax for overall drug liking VAS will be reported. Peak effect for overall drug liking based on bipolar VAS from 0 (strong disliking) to 100 (strong liking).

Time frame: 12 hour and 24 hour post-dose

Take Drug Again VAS (Emax)

Emax for take drug again VAS will be reported. Peak effect for take drug again based on bipolar VAS from 0 (definitely no) to 100 (definitely so).

Time frame: 12 hour and 24 hour post-dose

Subjective Drug Value (Emax)

Subjective drug value will be reported. The subjective drug value is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between drug administered and different monetary values.

Time frame: 12 hour and 24 hour post-dose

High VAS (Emax)

High VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 millimeter (mm) unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 = definitely so).

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Placebo will be administered orally as per assigned treatment sequence.

TEmax is defined as time to peak effect for drug liking (at this moment). 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).

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

Minimum Effect (Emin) for Drug Liking (At this Moment) VAS

Emin is defined as minimum effect for drug liking (at this moment). 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).

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

Time to Minimum Effect (TEmin) for Drug Liking (At this Moment) VAS

TEmin is defined as time to minimum effect for drug liking (at this moment). 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).

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

Time-averaged Area Under the Effects Curve (TA_AUE) for Drug Liking (At This Moment) VAS

TA\_AUE is defined as time-averaged area under the effects curve for drug liking (at this moment). 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).

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

TEmax of High VAS

TEmax of high VAS will be reported. High VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 = definitely so).

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

TA_AUE of High VAS

TA\_AUE of high VAS will be reported. High VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 = definitely so).

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

Emax of Good Effect VAS

Emax of good effect VAS will be reported. Good drug effects VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).

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

TEmax of Good Effects VAS

TEmax of good effects VAS will be reported. Good drug effects VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).

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

TA_AUE of Good Effects VAS

TA\_AUE of good effects VAS will be reported. Good drug effects VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).

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

Emax of Bad Effects VAS

Emax of bad effects VAS will be reported. Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').

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

TA_AUE of Bad Effects VAS

TA\_AUE for bad effects VAS will be reported. Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').

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

TEmax of Bad Effects VAS

TEmax of bad effects VAS will be reported. Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').

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

Emin of Drowsiness/Alertness VAS

Emin of Drowsiness/Alertness VAS will be reported. Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm).

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

TEmin of Drowsiness/Alertness VAS

TEmin of Drowsiness/Alertness VAS will be reported. Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm).

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

Time-averaged Area Over the Effect Time Curve (TA_AOE) of Drowsiness/Alertness VAS

TA\_AOE is defined as time-averaged area over the effect time curve. Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm).

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

Emin of Relaxation/Agitation VAS

Emin of relaxation/agitation VAS will be reported. Agitation/Relaxation VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).

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

TEmin of Relaxation/Agitation VAS

TEmin of relaxation/agitation VAS will be reported. Agitation/Relaxation VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).

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

TA_AOE of Relaxation/Agitation VAS

TA\_AOE of relaxation/agitation VAS will be reported. Agitation/Relaxation VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).

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

TEmax of Dizziness VAS

TEmax of dizziness VAS will be reported. Dizziness VAS assesses the effect of dizziness by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).

Time frame: Pre-dose up to 24 hour post-dose (up to Day 2)

Emax of Dizziness VAS

Emax of dizziness VAS will be reported. Dizziness VAS assesses the effect of dizziness by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).

Time frame: Pre-dose up to 24 hour post-dose (up to Day 2)

TA_AUE of Dizziness VAS

TA\_AUE of dizziness VAS will be reported. Dizziness VAS assesses the effect of dizziness by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).

Time frame: Pre-dose up to 24 hour post-dose (up to Day 2)

Emax of Any Effects VAS

Emax of any effects VAS will be reported. Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').

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

TEmax of Any Effects VAS

TEmax of any effects VAS will be reported. Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').

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

TA_AUE of Any Effects VAS

TA\_AUE of any effects VAS will be reported. Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so').

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

Drug Similarity VAS

Drug similarity VAS will be reported. The Drug Similarity unipolar VAS items provide an estimate of the drug class with which drug users identify the test drug. It is a unipolar scale ranging from 0 (not at all similar) to 100 points ( very similar).

Time frame: 24 hour post-dose

Percentage of Participants with Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

Time frame: Up to Week 20

Percentage of Participants with Serious Adverse Events (SAEs)

An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.

Time frame: Up to Week 20

Percentage of Participants with Abnormalities in Clinical Laboratory Parameters

Percentage of participants with abnormalities in clinical laboratory parameters (included hematology, clinical chemistry, and routine urinalysis) will be reported.

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

Percentage of Participants with Abnormalities in Vital Signs

Percentage of participants with abnormalities in vital signs (included temperature, pulse/heart rate, blood pressure \[diastolic and systolic\]) will be reported.

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

Emin of Modified Observer's Assessment of Alertness/Sedation (MOAA/S) of Composite and Sum Score

Emin of MOAA/S of composite and sum score will be reported. The MOAA/S is an observer-rated measure of alertness/sedation that is used widely in clinical research. The MOAA/S scores range from 5 (not sedated) to 0 (unarousable). The observer's assessment of alertness/sedation scale (OAA/S) was developed to measure the level of alertness in participants who are sedated. The OAA/S is a reliable validated measure and was shown to be sensitive to different levels of sedation and is composed of 4 assessment categories that include responsiveness, speech, facial expression, and eyes. The MOAA/S includes only the Responsiveness assessment category.

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

TA_AOE of MOAA/S of composite and sum score

TA\_AOE of MOAA/S of composite and sum score will be reported. The MOAA/S is an observer-rated measure of alertness/sedation that is used widely in clinical research. The MOAA/S scores range from 5 (not sedated) to 0 (unarousable). The observer's assessment of alertness/sedation scale (OAA/S) was developed to measure the level of alertness in participants who are sedated. The OAA/S is a reliable validated measure and was shown to be sensitive to different levels of sedation and is composed of 4 assessment categories that include responsiveness, speech, facial expression, and eyes. The MOAA/S includes only the Responsiveness assessment category.

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