Skip to main content
OpenTrials
Completed

NCT Number: NCT03907215

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

24 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACT541468

Drug

50 mg; film-coated tablet for oral use

ACT541468 placebo

Drug

film-coated tablet for oral use

Citalopram

Drug

20 mg; tablet tor oral use; for single- or repeated dosing

Primary outcomes

  1. Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation

    Time frame: From pre-dose to 8 hours after dosing on Day 1, Day 2, Day 3, Day 9, and Day 10

Other outcomes

  1. Number of participants with treatment-emergent AEs from study treatment administration up to EOS

    Time frame: AEs from Day 1 to EOS; for up to 15 days post-dose

  2. Number of participants with treatment-emergent SAEs from study treatment administration up to EOS

    Time frame: SAEs from Day 1 to EOS; for up to 50 days post-dose

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 8, 2019
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.