Clinical trial NCT03907215: A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-08
Enrollment: 24
Sex: ALL
Minimum age (years): 24
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation
timeFrame: From pre-dose to 8 hours after dosing on Day 1, Day 2, Day 3, Day 9, and Day 10
Secondary outcomes:
Other outcomes:
measure: Number of participants with treatment-emergent AEs from study treatment administration up to EOS
timeFrame: AEs from Day 1 to EOS; for up to 15 days post-dose
measure: Number of participants with treatment-emergent SAEs from study treatment administration up to EOS
timeFrame: SAEs from Day 1 to EOS; for up to 50 days post-dose
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: