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CompletedNCT03907215Updated Oct 31, 2019

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

A Phase 1 interventional study of ACT541468 and ACT541468 placebo in Healthy, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 1 site in Germany. Open to participants aged 24 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-31.

Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jun 2019, 7 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
24 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Idorsia Pharmaceuticals Ltd. is the lead sponsor of 102 studies on the registry; 5 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 9 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • 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 · Drug: ACT541468 placebo

  • 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 · Drug: ACT541468 placebo · Drug: Citalopram

Interventions

  • DrugACT541468

    50 mg; film-coated tablet for oral use

  • DrugACT541468 placebo

    film-coated tablet for oral use

  • DrugCitalopram

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

06

What researchers measure

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

07

Study locations

1 site
  • Parexel International GmbH
    Berlin, 14050, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03907215
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Responsible party
Sponsor
First posted
Apr 8, 2019
Start date
Apr 9, 2019
Primary completion
Jun 26, 2019
Completion
Jun 26, 2019
Last update
Oct 31, 2019

Study contacts

Clinical Trials
study director · Idorsia Pharmaceuticals Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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