HealthyPhase 1NCT04250506
A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects
A Phase 1 study testing Daridorexant and Moxifloxacin in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.
Trial summary
A study to assess the effect of single doses of daridorexant on electrocardiogram parameters in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Daridorexant and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCzechia
- Study dates
- 28 Feb 2020to 22 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
A study to assess the effect of single doses of daridorexant on electrocardiogram parameters in healthy subjects
- Conditions
- Healthy
- Being tested
- Daridorexant, Placebo, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaridorexantDrug
Daridorexant (ACT-541468) administered as film-coated tablets for oral use.
PlaceboDrug
Placebo administered as tablets for oral use.
MoxifloxacinDrug
Moxifloxacin administered as film-coated tablets for oral use.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Daridorexant 50 mg | Experimental | Daridorexant (ACT-541468) administered as film-coated tablets for oral use. Receives: Drug: Daridorexant |
| Treatment B: Daridorexant 200 mg | Experimental | Daridorexant (ACT-541468) administered as film-coated tablets (4 x 50 mg) for oral use. Receives: Drug: Daridorexant |
| Treatment C: Placebo | Placebo comparator | Placebo administered as tablets (4 x 50 mg) for oral use. Receives: Drug: Placebo |
| Treatment D: Moxifloxacin 400 mg | Active comparator | Moxifloxacin administered as film-coated tablets for oral use. Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected change from baseline in the HR-corrected QTcF (ΔΔQTcF)
Measured: 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 outcomes (4)
Plasma PK parameters of daridorexant: - AUC from 0 to 24 hours (AUC0-24)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start28 Feb 2020
- Primary completion22 Jul 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center, randomized, double-blind, placebo- and moxifloxacin-controlled, Phase 1 study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250506
- Sponsor's protocol ID
- ID-078-117
- Other IDs
- 2019-003843-31, 2019
- Status last verified
- Sep 2020
- First submitted
- 30 Jan 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schilling U, Henrich A, Muehlan C, Krause A, Dingemanse J, Ufer M. Impact of Daridorexant, a Dual Orexin Receptor Antagonist, on Cardiac Repolarization Following Bedtime Dosing: Results from a Thorough QT Study Using Concentration-QT Analysis. Clin Drug Investig. 2021 Aug;41(8):711-721. doi: 10.1007/s40261-021-01062-1. Epub 2021 Jul 31.
PubMed 34331678
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04250506
- Acronym / sponsor ID
- ID-078-117
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the effect of single doses of daridorexant on electrocardiogram parameters in healthy subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Single-center, randomized, double-blind, placebo- and moxifloxacin-controlled, Phase 1 study
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Daridorexant 50 mg | Experimental | Drug: DaridorexantDaridorexant (ACT-541468) administered as film-coated tablets for oral use. |
| Treatment B: Daridorexant 200 mg | Experimental | Drug: DaridorexantDaridorexant (ACT-541468) administered as film-coated tablets (4 x 50 mg) for oral use. |
| Treatment C: Placebo | Placebo comparator | Drug: PlaceboPlacebo administered as tablets (4 x 50 mg) for oral use. |
| Treatment D: Moxifloxacin 400 mg | Active comparator | Drug: MoxifloxacinMoxifloxacin administered as film-coated tablets for oral use. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaridorexantDaridorexant (ACT-541468) administered as film-coated tablets for oral use. | Drug | Treatment A: Daridorexant 50 mg, Treatment B: Daridorexant 200 mg |
| PlaceboPlacebo administered as tablets for oral use. | Drug | Treatment C: Placebo |
| MoxifloxacinMoxifloxacin administered as film-coated tablets for oral use. | Drug | Treatment D: Moxifloxacin 400 mg |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 34331678Schilling U, Henrich A, Muehlan C, Krause A, Dingemanse J, Ufer M. Impact of Daridorexant, a Dual Orexin Receptor Antagonist, on Cardiac Repolarization Following Bedtime Dosing: Results from a Thorough QT Study Using Concentration-QT Analysis. Clin Drug Investig. 2021 Aug;41(8):711-721. doi: 10.1007/s40261-021-01062-1. Epub 2021 Jul 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Daridorexant and Moxifloxacin in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04250506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.