- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04250506
A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects
September 15, 2020 updated by: Idorsia Pharmaceuticals Ltd.
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
A study to assess the effect of single doses of daridorexant on electrocardiogram parameters in healthy subjects
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pilsen, Czechia, 323 00
- CEPHA s.r.o.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- Negative serum pregnancy test at Screening.
- Negative serum pregnancy test on Day 1 of the first period.
- 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:
- Previous bilateral salpingectomy, salpingo-oophorectomy, or hysterectomy.
- Premature ovarian failure confirmed by a specialist gynecologist.
- Post-menopausal, defined as 12 consecutive months with amenorrhea prior to Screening without alternative medical cause and confirmed with follicle-stimulating hormone (FSH) test.
- XY genotype.
- Turner syndrome.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A: Daridorexant 50 mg
Daridorexant (ACT-541468) administered as film-coated tablets for oral use.
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Daridorexant (ACT-541468) administered as film-coated tablets for oral use.
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Experimental: Treatment B: Daridorexant 200 mg
Daridorexant (ACT-541468) administered as film-coated tablets (4 x 50 mg) for oral use.
|
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.
|
Placebo administered as tablets for oral use.
|
Active Comparator: Treatment D: Moxifloxacin 400 mg
Moxifloxacin administered as film-coated tablets for oral use.
|
Moxifloxacin administered as film-coated tablets for oral use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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
Outcome Measure |
Time Frame |
---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2020
Primary Completion (Actual)
July 22, 2020
Study Completion (Actual)
July 22, 2020
Study Registration Dates
First Submitted
January 30, 2020
First Submitted That Met QC Criteria
January 30, 2020
First Posted (Actual)
January 31, 2020
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 15, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-078-117
- 2019-003843-31 (EudraCT Number)
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
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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