A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects
Study Details
Study Description
Brief Summary
A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in healthy male and female subjects
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Treatment A and B On Day 1 and Day 2, subjects will EITHER receive: a single dose of 50 mg ACT-541468 (Treatment A) on Day 1 and a single dose of ACT- 541468 placebo (Treatment B) on Day 2 OR a single dose of ACT-541468 placebo (Treatment B) on Day 1 and a single dose of 50 mg ACT-541468 (Treatment A) on Day 2. |
Drug: ACT541468
50 mg; film-coated tablet for oral use
Drug: ACT541468 placebo
film-coated tablet for oral use
|
Other: Treatment C, D, E, and F From Day 3 to Day 10, subjects will on each day receive: • a single dose of 20 mg citalopram and EITHER a single dose of ACT-541468 placebo OR a single dose of 50 mg ACT-541468. |
Drug: ACT541468
50 mg; film-coated tablet for oral use
Drug: ACT541468 placebo
film-coated tablet for oral use
Drug: Citalopram
20 mg; tablet tor oral use; for single- or repeated dosing
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent prior to any study-mandated procedure.
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Healthy male and female subjects aged between 24 and 55 years (inclusive) at Screening.
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Body mass index of 18.5 to 29.9 kg/m2 (inclusive) at Screening.
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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.
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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).
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Healthy on the basis of physical examination, cardiovascular assessments, and clinical laboratory tests.
Exclusion Criteria:
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Pregnant or lactating women.
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Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
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Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy.
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Any contraindication to citalopram or any other selective serotonin reuptake inhibitor.
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History of cardiovascular disease (e.g., congenital long QT syndrome, arrhythmia).
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Relevant history of a suicide attempt or suicidal behavior.
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Personal or family history of psychiatric disorder(s).
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Individuals of Asian descent.
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History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
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Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
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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.
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Ongoing, recurrent, or chronic hypokalemia or hypomagnesemia.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Parexel International GmbH | Berlin | Germany | 14050 |
Sponsors and Collaborators
- Idorsia Pharmaceuticals Ltd.
Investigators
- Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ID-078-114