A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: ACT-541468
Other: Ethanol placebo
Other: ACT-541468 placebo
Other: Ethanol 10%
Details and patient eligibility
About
A study to investigate the drug-drug interactions between ACT-541468 and ethanol in healthy subjects
Enrollment
22 patients
Sex
All
Ages
18 to 45 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Signed informed consent prior to any study-mandated procedure.
- Healthy male and female subjects aged between 18 and 45 years (inclusive) at screening.
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use a reliable method of contraception, be sexually inactive, or have a vasectomized partner.
- Women of non-childbearing potential (i.e., postmenopausal).
- Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening.
- Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests.
- Previous experience with alcohol consumption and, therefore, familiar with the effects of alcohol.
Exclusion criteria
- Pregnant or lactating women.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
- Nicotine intake within 3 months prior to screening and inability to refrain from nicotine intake from screening until End-of-Study (EOS).
- Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first study treatment administration.
- History or clinical evidence of alcoholism or drug abuse.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females).
- Individuals of Asian descent or other individuals reporting ethanol intolerance.
- Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
22 participants in 4 patient groups
Treatment A (ethanol + ACT-541468)
Experimental group
Description:
5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of ACT-541468 (50 mg)
Treatment:
Drug: ACT-541468
Other: Ethanol 10%
Treatment B (ethanol placebo + ACT-541468)
Experimental group
Description:
5 h i.v. placebo clamp in combination with a single oral dose of ACT-541468 (50 mg)
Treatment:
Drug: ACT-541468
Other: Ethanol placebo
Treatment C (ethanol + ACT-541468 placebo)
Experimental group
Description:
5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of matching ACT-541468 placebo
Treatment:
Other: Ethanol 10%
Other: ACT-541468 placebo
Treatment D (ethanol placebo + ACT-541468 placebo)
Experimental group
Description:
5 h i.v. placebo clamp in combination with a single oral dose of matching ACT-541468 placebo
Treatment:
Other: Ethanol placebo
Other: ACT-541468 placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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