Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Recreational Drug Users
In brief
This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users
Key facts
- Study ID
- NCT03657355
- Run by
- Idorsia Pharmaceuticals Ltd.
- People needed
- 63
- Starts
- 2018-09-07
- Expected to finish
- 2019-08-08
- Last updated by the study team
- 2019-09-19
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Altasciences Clinical Kansas, Inc. (former Vince and Associates Clinical Research, Inc.) — Overland Park, Kansas, United States
- Altasciences Company Inc. — Montreal, Canada
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.