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

NCT03907215 | Completed Phase 1 FDA Drug

• 1 other identifier: ID-078-114
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• 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

• 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

Study Arms (2)

Treatment A and B

OTHER

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

Treatment C, D, E, and F

OTHER

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

ACT541468 DRUG

50 mg; film-coated tablet for oral use

Treatment A and B; Treatment C, D, E, and F

ACT541468 placebo DRUG

film-coated tablet for oral use

Treatment A and B; Treatment C, D, E, and F

Citalopram DRUG

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

Treatment C, D, E, and F

Eligibility Criteria

• Age: 24 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Parexel International GmbH

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

daridorexant; Citalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind to the administration of ACT-541468 (participant). Single- and double-blind to the administration of ACT-541468 (Investigator, single-/double blind is dependent on treatment arm team). Single-blind study with the inclusion of two double-blind nested crossover parts, i.e., subjects will remain blinded to all administrations of ACT-541468.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, single-blind, randomized, placebo-controlled, sequential design Phase 1 study with the inclusion of two double-blind nested crossover parts

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: April 8, 2019
• Study Start: April 9, 2019
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)