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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907215
• Other study ID #: ID-078-114
• Status: Completed
• Phase: Phase 1
• Start date: April 9, 2019
• Est. completion date: June 26, 2019

Study information

• Verified date: October 2019
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	Parexel International GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-emergent AEs from study treatment administration up to EOS		AEs from Day 1 to EOS; for up to 15 days post-dose
Other	Number of participants with treatment-emergent SAEs from study treatment administration up to EOS		SAEs from Day 1 to EOS; for up to 50 days post-dose
Primary	Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation		From pre-dose to 8 hours after dosing on Day 1, Day 2, Day 3, Day 9, and Day 10