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A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250506
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
A study to assess the effect of single doses of daridorexant on electrocardiogram parameters in healthy subjects

Condition or disease Intervention/treatment Phase
Healthy Drug: Daridorexant Drug: Placebo Drug: Moxifloxacin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-center, randomized, double-blind, placebo- and moxifloxacin-controlled, Phase 1 study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Single-center, Randomized, Double-blind, Placebo- and Moxifloxacin-controlled, Phase 1 Study to Assess the Effect of Single Therapeutic and Supratherapeutic Doses of Daridorexant on the QT Interval Duration in Healthy Subjects
Actual Study Start Date : February 28, 2020
Actual Primary Completion Date : July 22, 2020
Actual Study Completion Date : July 22, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A: Daridorexant 50 mg
Daridorexant (ACT-541468) administered as film-coated tablets for oral use.
Drug: Daridorexant
Daridorexant (ACT-541468) administered as film-coated tablets for oral use.

Experimental: Treatment B: Daridorexant 200 mg
Daridorexant (ACT-541468) administered as film-coated tablets (4 x 50 mg) for oral use.
Drug: Daridorexant
Daridorexant (ACT-541468) administered as film-coated tablets for oral use.

Placebo Comparator: Treatment C: Placebo
Placebo administered as tablets (4 x 50 mg) for oral use.
Drug: Placebo
Placebo administered as tablets for oral use.

Active Comparator: Treatment D: Moxifloxacin 400 mg
Moxifloxacin administered as film-coated tablets for oral use.
Drug: Moxifloxacin
Moxifloxacin administered as film-coated tablets for oral use.




Primary Outcome Measures :
  1. Placebo-corrected change from baseline in the HR-corrected QTcF (ΔΔQTcF) [ Time Frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks. ]

Secondary Outcome Measures :
  1. Plasma PK parameters of daridorexant: - AUC from 0 to 24 hours (AUC0-24) [ Time Frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks. ]
  2. Plasma PK parameters of daridorexant: - Maximum plasma concentration (Cmax) [ Time Frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks. ]
  3. Plasma PK parameters of daridorexant: - Time to reach Cmax (tmax) [ Time Frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks. ]
  4. Plasma PK parameters of daridorexant: - T½ [ Time Frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent in the local language prior to any study-mandated procedure.
  • Czech citizen with the ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the requirements of the study.
  • Healthy male and female subjects aged 18 to 55 years (inclusive) at Screening.
  • 12-lead safety ECG: QTcF < 450 ms for male subjects and < 470 ms for female subjects, QRS < 110 ms, and PR < 220 ms, and resting HR > 50 bpm and < 90 bpm with no clinically relevant abnormalities on 12-lead ECG after 5 min in the supine position at Screening and on Day 1 pre-dose of Period 1.
  • Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
  • Women of childbearing potential are eligible only if the following applies:

    1. Negative serum pregnancy test at Screening.
    2. Negative serum pregnancy test on Day 1 of the first period.
    3. Agreement to consistently and correctly use a highly effective method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner from Screening up to at least 30 days after last study treatment administration in the last period with wash-out periods included. If a hormonal contraceptive is used, it must be initiated at least 1 month before first treatment administration.
  • Women of non-childbearing potential must meet at least one of the following criteria:

    1. Previous bilateral salpingectomy, salpingo-oophorectomy, or hysterectomy.
    2. Premature ovarian failure confirmed by a specialist gynecologist.
    3. Post-menopausal, defined as 12 consecutive months with amenorrhea prior to Screening without alternative medical cause and confirmed with follicle-stimulating hormone (FSH) test.
    4. XY genotype.
    5. Turner syndrome.
    6. Uterine agenesis.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Previous exposure to daridorexant.
  • Known hypersensitivity to moxifloxacin or any of the drug product excipients or to other fluoroquinolone antibiotics.
  • Any contraindication to moxifloxacin treatment.
  • History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed).
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
  • History or presence of rhythm disorders (e.g., sinoatrial heart block, sick-sinus syndrome, second- or third-degree atrioventricular block, long QT syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation) or electrolyte disturbances, particularly hypokalemia.
  • Any sleep-disorder including self-reported insomnia disorder, breathing-related sleep disorders, restless legs syndrome, nightmare disorder, non-rapid eye movement sleep arousal disorders (sleep terror disorder or sleepwalking disorder), rapid eye movement sleep behavior disorder, circadian rhythm sleep-wake disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250506


Locations
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Czechia
CEPHA s.r.o.
Pilsen, Czechia, 323 00
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT04250506    
Other Study ID Numbers: ID-078-117
2019-003843-31 ( EudraCT Number )
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents