Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05106153 | A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem | PHASE1 | COMPLETED | 127 | — | — | Dec 17, 2021 | May 12, 2023 | Apr 27, 2025 | 1 | United States |
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).
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
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...