HealthyPhase 1NCT05877222
A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants
A Phase 1 study testing Daridorexant 10 mg and Daridorexant 25 mg in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in United States.
Trial summary
A Phase 1 trial to investigate bioequivalence between 5 × 10 mg tablets and 2 × 25 mg tablets of daridorexant in healthy male and female Japanese participants Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Daridorexant 10 mg and Daridorexant 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 4 Aug 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent in a language understandable to the participant prior to any trial-mandated procedure.
- Healthy male and female participants aged between 18 and 65 years (inclusive) at Screening.
- Body mass index of 18.5 to 29.9 kg/m2 (inclusive) at Screening.
- Participant must be of native Japanese descent (all parents/grandparents of Japanese descent).
- Participant must not have been away from Japan for more than 10 years (at Screening visit).
- Participant's lifestyle should not have changed significantly since relocation from Japan.
Who cannot join
- Known hypersensitivity to daridorexant, or any of its excipients.
- History of narcolepsy or cataplexy.
- Clinically relevant findings on the physical examination at Screening.
- Clinically relevant findings on 12-lead ECG, recorded after 5 min in a supine position at Screening.
- Clinically relevant findings in clinical laboratory tests (hematology and clinical chemistry) at Screening.
- Clinically relevant findings in systolic blood pressure, diastolic blood pressure, and pulse rate, measured on either arm, after 5 min in the supine position at Screening.
- 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 treatment (appendectomy and herniotomy allowed if performed > 12 weeks prior to administration of first study treatment, 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Randomized, Crossover Phase 1 Trial to Investigate Bioequivalence Between 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants
A Phase 1 trial to investigate bioequivalence between 5 × 10 mg tablets and 2 × 25 mg tablets of daridorexant in healthy male and female Japanese participants
- Conditions
- Healthy
- Being tested
- Daridorexant 10 mg, Daridorexant 25 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daridorexant 10 mgDrug
Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 10 mg.
Daridorexant 25 mgDrug
Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 25 mg.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (5 × 10 mg daridorexant) | Experimental | Participants will receive a single oral dose of 5 × 10 mg daridorexant. Receives: Drug: Daridorexant 10 mg |
| Treatment B (5 × 25 mg daridorexant) | Experimental | Participants will receive a single oral dose of 2 × 25 mg daridorexant. Receives: Drug: Daridorexant 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: Blood samples for PK analysis will be taken at several timepoints from treatment administration on Day 1 to Day 3 of Study periods 1 and 2 (Total duration: up to 4 days)
AUC0-t
Measured: Blood samples for PK analysis will be taken at several timepoints from treatment administration on Day 1 to Day 3 of Study periods 1 and 2 (Total duration: up to 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start23 Jun 2023
- Primary completion4 Aug 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials Study Director, Study director, Idosia Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877222
- Sponsor's protocol ID
- ID-078-127
- Status last verified
- Aug 2023
- First submitted
- 17 May 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Randomized, Crossover Phase 1 Trial to Investigate Bioequivalence Between 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants
- ClinicalTrials.gov ID
- NCT05877222
- Acronym / sponsor ID
- ID-078-127
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 26 May 2023 (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 Phase 1 trial to investigate bioequivalence between 5 × 10 mg tablets and 2 × 25 mg tablets of daridorexant in healthy male and female Japanese participants
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A (5 × 10 mg daridorexant) | Experimental | Drug: Daridorexant 10 mgParticipants will receive a single oral dose of 5 × 10 mg daridorexant. |
| Treatment B (5 × 25 mg daridorexant) | Experimental | Drug: Daridorexant 25 mgParticipants will receive a single oral dose of 2 × 25 mg daridorexant. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent in a language understandable to the participant prior to any trial-mandated procedure.
- Healthy male and female participants aged between 18 and 65 years (inclusive) at Screening.
- Body mass index of 18.5 to 29.9 kg/m2 (inclusive) at Screening.
- Participant must be of native Japanese descent (all parents/grandparents of Japanese descent).
- Participant must not have been away from Japan for more than 10 years (at Screening visit).
Key exclusion criteria (8 listed)
- Known hypersensitivity to daridorexant, or any of its excipients.
- History of narcolepsy or cataplexy.
- Clinically relevant findings on the physical examination at Screening.
- Clinically relevant findings on 12-lead ECG, recorded after 5 min in a supine position at Screening.
- Clinically relevant findings in clinical laboratory tests (hematology and clinical chemistry) at Screening.
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 |
|---|---|---|
| Daridorexant 10 mgDaridorexant will be available as film-coated tablets for oral administration formulated at strengths of 10 mg. | Drug | Treatment A (5 × 10 mg daridorexant) |
| Daridorexant 25 mgDaridorexant will be available as film-coated tablets for oral administration formulated at strengths of 25 mg. | Drug | Treatment B (5 × 25 mg daridorexant) |
Primary outcome
Cmax
Time frame: Blood samples for PK analysis will be taken at several timepoints from treatment administration on Day 1 to Day 3 of Study periods 1 and 2 (Total duration: up to 4 days)
AUC0-t
Time frame: Blood samples for PK analysis will be taken at several timepoints from treatment administration on Day 1 to Day 3 of Study periods 1 and 2 (Total duration: up to 4 days)
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 Aug 2023.
- 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 study director
Idosia 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 10 mg and Daridorexant 25 mg in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in United States.
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 6 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 Aug 2023. 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 United States. 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. 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?
Cmax (time frame: Blood samples for PK analysis will be taken at several timepoints from treatment administration on Day 1 to Day 3 of Study periods 1 and 2 (Total duration: up to 4 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2023.