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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922MDD1017 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug | Suvorexant will be administered orally as per assigned treatment sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 24 hour post-dose (up to Day 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 hour and 24 hour post-dose |
| Take Drug Again VAS (Emax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Inc. | Overland Park | Kansas | 66212 | United States |
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
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| ID | Term |
|---|---|
| C551624 | suvorexant |
| D000077334 | Zolpidem |
| C000655226 | seltorexant |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Zolpidem | Drug | Zolpidem will be administered orally as per assigned treatment sequence. |
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| Seltorexant | Drug | Seltorexant will be administered orally as per assigned treatment sequence. |
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| Placebo | Drug | Placebo will be administered orally as per assigned treatment sequence. |
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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).
| 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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'). | 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'). | 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'). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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'). | 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'). | 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'). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | Up to 24 hour post-dose (up to Day 2) |