A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects
NCT ID: NCT03907215
Last Updated: 2019-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2019-04-09
2019-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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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.
ACT541468
50 mg; film-coated tablet for oral use
ACT541468 placebo
film-coated tablet for oral use
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.
ACT541468
50 mg; film-coated tablet for oral use
ACT541468 placebo
film-coated tablet for oral use
Citalopram
20 mg; tablet tor oral use; for single- or repeated dosing
Interventions
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ACT541468
50 mg; film-coated tablet for oral use
ACT541468 placebo
film-coated tablet for oral use
Citalopram
20 mg; tablet tor oral use; for single- or repeated dosing
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
24 Years
55 Years
ALL
Yes
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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Parexel International GmbH
Berlin, , Germany
Countries
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Other Identifiers
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ID-078-114
Identifier Type: -
Identifier Source: org_study_id