Healthy Recreational Drug Users Clinical Trial
Official title:
Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, 6-way Cross-over Study to Evaluate the Abuse Potential of Single, Oral Doses of ACT-541468 in Healthy Recreational Drug Users
| Verified date | September 2019 |
| Source | Idorsia Pharmaceuticals Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users
| Status | Completed |
| Enrollment | 63 |
| Est. completion date | August 8, 2019 |
| Est. primary completion date | August 8, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Altasciences Company Inc. | Montreal | |
| United States | Altasciences Clinical Kansas, Inc. (former Vince and Associates Clinical Research, Inc.) | Overland Park | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Idorsia Pharmaceuticals Ltd. |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | AUC(0-t) of ACT-541468 | Duration: for up to 24 hours post-dose | ||
| Other | AUC(0-8) of ACT-541468 | Duration: for up to 24 hours post-dose | ||
| Other | Cmax of ACT-541468 | Duration: for up to 24 hours post-dose | ||
| Other | tmax of ACT-541468 | Duration: for up to 24 hours post-dose | ||
| Other | t½ of ACT-541468 | Duration: for up to 24 hours post-dose | ||
| Other | Treatment-emergent adverse events (AEs) | All AEs from (first) admittance on Day -1 up to EOS, i.e. for up to 9 weeks | ||
| Other | Treatment-emergent serious AEs (SAEs) | SAE reporting: from signature of informed consent up to EOS, i.e. for up to 13 weeks | ||
| Primary | Maximum effect (Emax) of the Drug Liking VAS ('at this moment') over 24 h post-dose during each treatment period | VAS = visual analogue scale | Duration: for up to 24 hours post-dose | |
| Secondary | Drug Liking VAS (bipolar) | VAS = visual analogue scale | Duration: for up to 24 hours post-dose | |
| Secondary | Overall Drug Liking VAS (bipolar) | VAS = visual analogue scale | Duration: for up to 12 hours post-dose | |
| Secondary | Take Drug Again VAS (bipolar) | Duration: for up to 12 hours post-dose | ||
| Secondary | Good Effects VAS (unipolar) | Duration: for up to 24 hours post-dose | ||
| Secondary | Drug Similarity VAS | VAS = visual analogue scale | Duration: for up to 1 hour post-dose | |
| Secondary | Bad Effects VAS (unipolar) | VAS = visual analogue scale | Duration: for up to 24 hours post-dose | |
| Secondary | Alertness/Drowsiness VAS (bipolar) | VAS = visual analogue scale | Duration: for up to 24 hours post-dose | |
| Secondary | Any Effects VAS (unipolar) | VAS = visual analogue scale | Duration: for up to 24 hours post-dose | |
| Secondary | Feeling High VAS (unipolar) | VAS = visual analogue scale | Duration: for up to 24 hours post-dose | |
| Secondary | Bowdle VAS Internal and External Perceptions | Duration: for up to 24 hours post-dose | ||
| Secondary | Observer's Assessment of Alertness/Sedation composite and sum scores | Duration: for up to 24 hours post-dose | ||
| Secondary | Reaction time task score | Duration: for up to 8 hours post-dose | ||
| Secondary | Rapid visual information processing score | Duration: for up to 8 hours post-dose | ||
| Secondary | Paired Associates Learning score | Duration: for up to 8 hours post-dose |