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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Recreational Drug Users

Treatments: Drug: Suvorexant; Drug: ACT-541468; Drug: Placebo; Drug: Zolpidem

Study type: Interventional

Funder types: Industry

Identifiers

NCT03657355

ID-078-107

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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63 participants in 6 patient groups, including a placebo group

50 mg ACT-541468

Experimental group

Description:

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

Treatment:

Drug: ACT-541468

100 mg ACT-541468

Experimental group

Description:

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

Treatment:

Drug: ACT-541468

150 mg ACT-541468

Experimental group

Description:

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

Treatment:

Drug: ACT-541468

150 mg suvorexant

Active Comparator group

Description:

Suvorexant will be administered as tablets for oral use.

Treatment:

Drug: Suvorexant

30 mg zolpidem

Active Comparator group

Description:

Zolpidem will be administered as tablets for oral use.

Treatment:

Drug: Zolpidem

Placebo

Placebo Comparator group

Description:

Placebo will be administered as tablets for oral use.

Treatment:

Drug: Placebo