Healthy Recreational Drug Users
Conditions
Brief summary
This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users
Interventions
DRUGACT-541468
ACT-541468 will be administered as 50 mg tablets for oral use.
DRUGSuvorexant
Suvorexant will be administered as 15 mg over-encapsulated tablets for oral use.
DRUGZolpidem
Zolpidem will be administered as 10 mg over-encapsulated tablets for oral use.
DRUGPlacebo
Matching-placebo will be used.
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
For blinding purposes, suvorexant and zolpidem will be over-encapsulated, whereas a matching-placebo will be used for ACT-541468.
Intervention model description
Single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 6-way cross-over study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent prior to any study-mandated procedure * Male or female healthy subjects, 18-55 years of age (inclusive) at Screening * Body mass index of 18.0-33.0 kg/m2 (inclusive) at Screening and a minimum weight of 50.0 kg at Screening * Current sedative users who have used sedatives (e.g., benzodiazepines, zolpidem, eszopiclone, gamma-hydroxybutyrate, barbiturates) for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least ten times in their life and at least once in the 12 weeks before Screening * Women of childbearing potential must consistently and correctly use a reliable method of contraception with a failure rate of \< 1% per year, be sexually inactive, or have a vasectomized partner * Women of non-childbearing potential * Male subjects are required to use a medically acceptable method of contraception throughout the entire study period and for at least 90 days after last study drug administration
Exclusion criteria
* History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) * Positive HIV or hepatitis B/C test at Screening * Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 1 month of the last study treatment administration * Modified Swiss Narcolepsy Scale total score \< 0 at Screening or history of narcolepsy or cataplexy * Substance or alcohol dependence within 2 years prior to Screening or prior participation in a substance or alcohol dependence rehabilitation program * Subjects who have a positive urine drug screen at admittance to the qualification or core phase * Any sleep-disorder including self-reported insomnia disorder, breathing-related sleep disorders, restless legs syndrome (RLS), nightmare disorder, non-rapid eye movement (REM), sleep arousal disorders, REM sleep behavior disorder, circadian rhythm sleep-wake disorders, or narcolepsy * Any of the following SLEEP-50 Questionnaire scores at Screening: * ≥ 15 on Apnea subscale; * ≥ 7 on Narcolepsy subscale; * ≥ 7 on RLS or Periodic limb movement disorder subscale; * ≥ 8 on Circadian Rhythm subscale; * ≥ 7 on Sleepwalking subscale; * ≥ 3 on Item 32 and ≥ 9 on Items 33 to 35 (i.e., on nightmare subscale); * ≥ 15 on Impact subscale. * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum effect (Emax) of the Drug Liking VAS ('at this moment') over 24 h post-dose during each treatment period | Duration: for up to 24 hours post-dose | VAS = visual analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Similarity VAS | Duration: for up to 1 hour post-dose | VAS = visual analogue scale |
| Any Effects VAS (unipolar) | Duration: for up to 24 hours post-dose | VAS = visual analogue scale |
| Feeling High VAS (unipolar) | Duration: for up to 24 hours post-dose | VAS = visual analogue scale |
| Bowdle VAS Internal and External Perceptions | Duration: for up to 24 hours post-dose | — |
| Observer's Assessment of Alertness/Sedation composite and sum scores | Duration: for up to 24 hours post-dose | — |
| Reaction time task score | Duration: for up to 8 hours post-dose | — |
| Rapid visual information processing score | Duration: for up to 8 hours post-dose | — |
| Paired Associates Learning score | Duration: for up to 8 hours post-dose | — |
| Drug Liking VAS (bipolar) | Duration: for up to 24 hours post-dose | VAS = visual analogue scale |
| Overall Drug Liking VAS (bipolar) | Duration: for up to 12 hours post-dose | VAS = visual analogue scale |
| Take Drug Again VAS (bipolar) | Duration: for up to 12 hours post-dose | — |
| Good Effects VAS (unipolar) | Duration: for up to 24 hours post-dose | — |
| Bad Effects VAS (unipolar) | Duration: for up to 24 hours post-dose | VAS = visual analogue scale |
| Alertness/Drowsiness VAS (bipolar) | Duration: for up to 24 hours post-dose | VAS = visual analogue scale |
Other
| Measure | Time frame |
|---|---|
| Cmax of ACT-541468 | Duration: for up to 24 hours post-dose |
| tmax of ACT-541468 | Duration: for up to 24 hours post-dose |
| t½ of ACT-541468 | Duration: for up to 24 hours post-dose |
| Treatment-emergent adverse events (AEs) | All AEs from (first) admittance on Day -1 up to EOS, i.e. for up to 9 weeks |
| Treatment-emergent serious AEs (SAEs) | SAE reporting: from signature of informed consent up to EOS, i.e. for up to 13 weeks |
| AUC(0-t) of ACT-541468 | Duration: for up to 24 hours post-dose |
| AUC(0-∞) of ACT-541468 | Duration: for up to 24 hours post-dose |
Countries
Canada, United States
Outcome results
None listed