A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects

A Single-center, Single-blind, Randomized, Placebo-controlled, Sequential Design Phase 1 Study With the Inclusion of Two Double-blind Nested Crossover Parts to Investigate the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects

A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in healthy male and female subjects

Inclusion Criteria:

• Signed informed consent prior to any study-mandated procedure.
• Healthy male and female subjects aged between 24 and 55 years (inclusive) at Screening.
• Body mass index of 18.5 to 29.9 kg/m2 (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. They must consistently and correctly use a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.
• Women of non-childbearing potential (i.e., postmenopausal, with previous bilateral salpingectomy, bilateral salpingo oophorectomy or hysterectomy, or with premature ovarian failure, XY genotype, Turner syndrome, uterine agenesis).
• Healthy on the basis of physical examination, cardiovascular assessments, and clinical laboratory tests.

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.
• Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy.
• Any contraindication to citalopram or any other selective serotonin reuptake inhibitor.
• History of cardiovascular disease (e.g., congenital long QT syndrome, arrhythmia).
• Relevant history of a suicide attempt or suicidal behavior.
• Personal or family history of psychiatric disorder(s).
• Individuals of Asian descent.
• History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
• Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
• 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 or 5 terminal half-lives (t½; whichever is longer) prior to first study treatment administration.
• Ongoing, recurrent, or chronic hypokalemia or hypomagnesemia.