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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ACT541468; Drug: ACT541468 placebo; Drug: Citalopram

• Registration Number: NCT03907215
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Study Start: 2019-04-09
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A and B	ACT541468 placebo	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.
Treatment C, D, E, and F	ACT541468 placebo	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.
Treatment A and B	ACT541468	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.
Treatment C, D, E, and F	ACT541468	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.
Treatment C, D, E, and F	Citalopram	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Parexel International GmbH; 🇩🇪 Berlin, Germany