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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Citalopram; Drug: ACT541468 placebo; Drug: ACT541468

Study type: Interventional

Funder types: Industry

Identifiers

NCT03907215

ID-078-114

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 24 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Treatment A and B

Other group

Description:

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.

Treatment:

Drug: ACT541468 placebo

Drug: ACT541468

Treatment C, D, E, and F

Other group

Description:

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.

Treatment:

Drug: ACT541468 placebo

Drug: ACT541468

Drug: Citalopram