Healthy Non-dependent, Recreational Sedative UsersPhase 1NCT05106153
A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem
A Phase 1 study testing Suvorexant, Zolpidem and Seltorexant in people with Healthy Non-dependent, Recreational Sedative Users and Abuse Potential, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Non-dependent, Recreational Sedative Users, Abuse Potential
- What is being tested?
- Suvorexant, Zolpidem and Seltorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2021to 12 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Suvorexant, Zolpidem, Seltorexant, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvorexantDrug
Suvorexant will be administered orally as per assigned treatment sequence.
ZolpidemDrug
Zolpidem will be administered orally as per assigned treatment sequence.
SeltorexantDrug
Also called JNJ-42847922
Seltorexant will be administered orally as per assigned treatment sequence.
PlaceboDrug
Placebo will be administered orally as per assigned treatment sequence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Suvorexant; Drug: Zolpidem; Drug: Seltorexant; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 24 hour post-dose (up to Day 2)
Secondary outcomes (35)
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Pre-dose up to 24 hours post-dose (up to Day 2)
Time to Peak Effect (TEmax) for Drug Liking (At this Moment) VAS
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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').
Measured: 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').
Measured: 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').
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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').
Measured: 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').
Measured: 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').
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 hour post-dose (up to Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start17 Dec 2021
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Non-dependent, Recreational Sedative UsersStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106153
- Sponsor's protocol ID
- CR109099
- Other IDs
- 42847922MDD1017
- Status last verified
- Apr 2025
- First submitted
- 21 Oct 2021
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05106153
- Acronym / sponsor ID
- CR109099
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Qualification Phase: Treatment Sequence YXZ | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: PlaceboParticipants 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. |
| Qualification Phase: Treatment Sequence ZYX | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: PlaceboParticipants 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. |
| Qualification Phase: Treatment Sequence XZY | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: PlaceboParticipants 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. |
| Qualification Phase: Treatment Sequence YZX | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: PlaceboParticipants 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. |
| Qualification Phase: Treatment Sequence ZXY | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: PlaceboParticipants 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. |
| Qualification Phase: Treatment Sequence XYZ | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: PlaceboParticipants 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 Phase: Treatment Sequence ABFCED | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: Seltorexant, Drug: PlaceboParticipants 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 Phase: Treatment Sequence BCADFE | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: Seltorexant, Drug: PlaceboParticipants 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 Phase: Treatment Sequence CDBEAF | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: Seltorexant, Drug: PlaceboParticipants 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 Phase: Treatment Sequence DECFBA | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: Seltorexant, Drug: PlaceboParticipants 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 Phase: Treatment Sequence: EFDACB | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: Seltorexant, Drug: PlaceboParticipants 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 Phase: Treatment Sequence FAEBDC | Experimental | Drug: Suvorexant, Drug: Zolpidem, Drug: Seltorexant, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuvorexantSuvorexant will be administered orally as per assigned treatment sequence. | Drug | 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 |
| ZolpidemZolpidem will be administered orally as per assigned treatment sequence. | Drug | 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 |
| SeltorexantAlso: JNJ-42847922Seltorexant will be administered orally as per assigned treatment sequence. | Drug | 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 |
| PlaceboPlacebo will be administered orally as per assigned treatment sequence. | Drug | 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 |
Primary outcome
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)
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).
35 secondary outcomes
Overall Drug Liking VAS (Emax)
Time frame: 12 hour and 24 hour post-dose
Take Drug Again VAS (Emax)
Time frame: 12 hour and 24 hour post-dose
Subjective Drug Value (Emax)
Time frame: 12 hour and 24 hour post-dose
High VAS (Emax)
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
Time frame: Up to 24 hour post-dose (up to Day 2)
Minimum Effect (Emin) for Drug Liking (At this Moment) VAS
Time frame: Up to 24 hour post-dose (up to Day 2)
Time to Minimum Effect (TEmin) for Drug Liking (At this Moment) VAS
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
Time frame: Up to 24 hour post-dose (up to Day 2)
TEmax of High VAS
Time frame: Pre-dose up to 24 hours post-dose (up to Day 2)
TA_AUE of High VAS
Time frame: Pre-dose up to 24 hours post-dose (up to Day 2)
Emax of Good Effect VAS
Time frame: Up to 24 hour post-dose (up to Day 2)
TEmax of Good Effects VAS
Time frame: Up to 24 hour post-dose (up to Day 2)
TA_AUE of Good Effects VAS
Time frame: Up to 24 hour post-dose (up to Day 2)
Emax of Bad Effects VAS
Time frame: Up to 24 hour post-dose (up to Day 2)
TA_AUE of Bad Effects VAS
Time frame: Up to 24 hour post-dose (up to Day 2)
TEmax of Bad Effects VAS
Time frame: Up to 24 hour post-dose (up to Day 2)
Emin of Drowsiness/Alertness VAS
Time frame: Pre-dose up to 24 hours post-dose (up to Day 2)
TEmin of Drowsiness/Alertness VAS
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
Time frame: Pre-dose up to 24 hours post-dose (up to Day 2)
Emin of Relaxation/Agitation VAS
Time frame: Pre-dose up to 24 hours post-dose (up to Day 2)
TEmin of Relaxation/Agitation VAS
Time frame: Pre-dose up to 24 hours post-dose (up to Day 2)
TA_AOE of Relaxation/Agitation VAS
Time frame: Pre-dose up to 24 hours post-dose (up to Day 2)
TEmax of Dizziness VAS
Time frame: Pre-dose up to 24 hour post-dose (up to Day 2)
Emax of Dizziness VAS
Time frame: Pre-dose up to 24 hour post-dose (up to Day 2)
TA_AUE of Dizziness VAS
Time frame: Pre-dose up to 24 hour post-dose (up to Day 2)
Emax of Any Effects VAS
Time frame: Up to 24 hour post-dose (up to Day 2)
TEmax of Any Effects VAS
Time frame: Up to 24 hour post-dose (up to Day 2)
TA_AUE of Any Effects VAS
Time frame: Up to 24 hour post-dose (up to Day 2)
Drug Similarity VAS
Time frame: 24 hour post-dose
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to Week 20
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Week 20
Percentage of Participants with Abnormalities in Clinical Laboratory Parameters
Time frame: Up to 24 hour post-dose (up to Day 2)
Percentage of Participants with Abnormalities in Vital Signs
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
Time frame: Up to 24 hour post-dose (up to Day 2)
TA_AOE of MOAA/S of composite and sum score
Time frame: Up to 24 hour post-dose (up to Day 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Suvorexant, Zolpidem and Seltorexant in people with Healthy Non-dependent, Recreational Sedative Users and Abuse Potential, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.