Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users

NCT03657355 | Completed Phase 1 FDA Drug

• 1 other identifier: ID-078-107
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 2

Brief Summary

This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users

Conditions

Healthy Recreational Drug Users

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Drug Liking VAS (bipolar)

  Duration: for up to 24 hours post-dose

• Overall Drug Liking VAS (bipolar)

  Duration: for up to 12 hours post-dose

• 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

• Drug Similarity VAS

  Duration: for up to 1 hour post-dose

Other Outcomes (7)

• 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

• Cmax of ACT-541468

  Duration: for up to 24 hours post-dose

Study Arms (6)

50 mg ACT-541468

EXPERIMENTAL

ACT-541468 will be administered as tablets for oral use.

Drug: ACT-541468

100 mg ACT-541468

EXPERIMENTAL

ACT-541468 will be administered as tablets for oral use.

Drug: ACT-541468

150 mg ACT-541468

EXPERIMENTAL

ACT-541468 will be administered as tablets for oral use.

Drug: ACT-541468

150 mg suvorexant

ACTIVE COMPARATOR

Suvorexant will be administered as tablets for oral use.

Drug: Suvorexant

30 mg zolpidem

ACTIVE COMPARATOR

Zolpidem will be administered as tablets for oral use.

Drug: Zolpidem

Placebo

PLACEBO COMPARATOR

Placebo will be administered as tablets for oral use.

Drug: Placebo

Interventions

ACT-541468 DRUG

ACT-541468 will be administered as 50 mg tablets for oral use.

100 mg ACT-541468; 150 mg ACT-541468; 50 mg ACT-541468

Suvorexant DRUG

Suvorexant will be administered as 15 mg over-encapsulated tablets for oral use.

150 mg suvorexant

Zolpidem DRUG

Zolpidem will be administered as 10 mg over-encapsulated tablets for oral use.

30 mg zolpidem

Placebo DRUG

Matching-placebo will be used.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (2)

Altasciences Clinical Kansas, Inc. (former Vince and Associates Clinical Research, Inc.)

Overland Park, Kansas, 66212, United States

Location

Altasciences Company Inc.

Montreal, H3P 3P1, Canada

Location

Related Publications (1)

• Ufer M, Kelsh D, Schoedel KA, Dingemanse J. Abuse potential assessment of the new dual orexin receptor antagonist daridorexant in recreational sedative drug users as compared to suvorexant and zolpidem. Sleep. 2022 Mar 14;45(3):zsab224. doi: 10.1093/sleep/zsab224.

  PMID: 34480579 DERIVED

MeSH Terms

Interventions

daridorexant; suvorexant; Zolpidem

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For blinding purposes, suvorexant and zolpidem will be over-encapsulated, whereas a matching-placebo will be used for ACT-541468.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 6-way cross-over study

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: September 7, 2018
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)