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

NCT ID: NCT03657355

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2019-08-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

50 mg ACT-541468

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

Group Type: EXPERIMENTAL

ACT-541468

Intervention Type: DRUG

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

100 mg ACT-541468

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

Group Type: EXPERIMENTAL

ACT-541468

Intervention Type: DRUG

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

150 mg ACT-541468

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

Group Type: EXPERIMENTAL

ACT-541468

Intervention Type: DRUG

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

150 mg suvorexant

Suvorexant will be administered as tablets for oral use.

Group Type: ACTIVE_COMPARATOR

Suvorexant

Intervention Type: DRUG

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

30 mg zolpidem

Zolpidem will be administered as tablets for oral use.

Group Type: ACTIVE_COMPARATOR

Zolpidem

Intervention Type: DRUG

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

Placebo

Placebo will be administered as tablets for oral use.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching-placebo will be used.

Interventions

ACT-541468

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

Intervention Type: DRUG

Suvorexant

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

Intervention Type: DRUG

Zolpidem

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

Intervention Type: DRUG

Placebo

Matching-placebo will be used.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

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

Overland Park, Kansas, United States

Altasciences Company Inc.

Montreal, , Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 34480579 (View on PubMed)

Other Identifiers

ID-078-107

Identifier Type: -

Identifier Source: org_study_id