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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ACT541468; Drug: ACT541468 placebo; Drug: Citalopram

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Parexel International GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 50 mg; film-coated tablet for oral use; Drug: ACT541468 placebo; film-coated tablet for oral use
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; 50 mg; film-coated tablet for oral use; Drug: ACT541468 placebo; film-coated tablet for oral use; Drug: Citalopram; 20 mg; tablet tor oral use; for single- or repeated dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 9, 2019
• Primary Completion (ACTUAL): June 26, 2019
• Study Completion (ACTUAL): June 26, 2019

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (ACTUAL): April 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: ID-078-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No