Healthy
Conditions
Brief summary
A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in healthy male and female subjects
Interventions
DRUGACT541468
50 mg; film-coated tablet for oral use
DRUGACT541468 placebo
film-coated tablet for oral use
DRUGCitalopram
20 mg; tablet tor oral use; for single- or repeated dosing
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind to the administration of ACT-541468 (participant). Single- and double-blind to the administration of ACT-541468 (Investigator, single-/double blind is dependent on treatment arm team). Single-blind study with the inclusion of two double-blind nested crossover parts, i.e., subjects will remain blinded to all administrations of ACT-541468.
Intervention model description
Single-center, single-blind, randomized, placebo-controlled, sequential design Phase 1 study with the inclusion of two double-blind nested crossover parts
Eligibility
Sex/Gender
ALL
Age
24 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation | From pre-dose to 8 hours after dosing on Day 1, Day 2, Day 3, Day 9, and Day 10 |
Other
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent AEs from study treatment administration up to EOS | AEs from Day 1 to EOS; for up to 15 days post-dose |
| Number of participants with treatment-emergent SAEs from study treatment administration up to EOS | SAEs from Day 1 to EOS; for up to 50 days post-dose |
Countries
Germany
Outcome results
None listed