HealthyPhase 1NCT04390334
A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant.
A Phase 1 study testing Daridorexant, Famotidine and Efavirenz in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
Trial summary
A study in healthy male subjects to investigate the effect of famotidine and efavirenz on the way the body takes up, distributes, and gets rid of daridorexant. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Daridorexant, Famotidine and Efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 13 May 2020to 26 Jun 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Healthy male subjects aged between 18 and 45 years (inclusive) at Screening.
Who cannot join
- Clinically relevant findings on the physical examination at Screening.
- Clinically relevant abnormalities on 12-lead ECG, measured after at least 5 min in a supine position at Screening.
- Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry) at Screening and on Day -1.
- 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(s) (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.
- Moderate or severe renal insufficiency (creatinine clearance < 60 mL/min calculated with the Cockcroft Gault formula) at Screening.
- Total bilirubin > 1.5 x Upper Limit of Normal at Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Randomized, Open-label Study to Investigate the Effect of Single-dose Famotidine and Multiple-dose Efavirenz on the Pharmacokinetics of Daridorexant in Healthy Male Subjects
A study in healthy male subjects to investigate the effect of famotidine and efavirenz on the way the body takes up, distributes, and gets rid of daridorexant.
- Conditions
- Healthy
- Being tested
- Daridorexant, Famotidine, Efavirenz
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaridorexantDrug
Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.
FamotidineDrug
Famotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions.
EfavirenzDrug
Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Daridorexant | Experimental | Single dose of 50 mg daridorexant Receives: Drug: Daridorexant |
| Treatment B: Famotidine & daridorexant | Experimental | Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant Receives: Drug: Daridorexant; Drug: Famotidine |
| Treatment C: Efavirenz | Experimental | 600 mg efavirenz once daily in the evening from Day 5 to Day 14 Receives: Drug: Efavirenz |
| Treatment D: Daridorexant & efavirenz | Experimental | Single dose of 50 mg daridorexant in the morning of Day 15 followed by a single dose of 600 mg efavirenz in the evening of Days 15 and 16 Receives: Drug: Daridorexant; Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter of daridorexant: Maximum plasma concentration (Cmax)
Measured: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: Time to reach Cmax (tmax)
Measured: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: AUC from zero to infinity (AUC0-inf)
Measured: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: AUC from zero to 48 hours (AUC0-48)
Measured: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: Terminal elimination half-life (t½)
Measured: Various time points during Treatment A through D (Total duration: up to 3 weeks).
Secondary outcomes (1)
Treatment-emergent (S)AEs
Measured: Up to EOP for each of the Periods 1 to 3 and up to EOS for Period 4 (Total duration: up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start13 May 2020
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
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
- Model description
- 4 treatment arms in 2 sequences, ABCD or BACD.
- Masking
- None (open label)
- Enrolment
- 24 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, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390334
- Sponsor's protocol ID
- ID-078-120
- Other IDs
- 2020-000653-27
- Status last verified
- Sep 2020
- First submitted
- 12 May 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
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
- Single-center, Randomized, Open-label Study to Investigate the Effect of Single-dose Famotidine and Multiple-dose Efavirenz on the Pharmacokinetics of Daridorexant in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04390334
- Acronym / sponsor ID
- ID-078-120
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 May 2020 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 15 May 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 in healthy male subjects to investigate the effect of famotidine and efavirenz on the way the body takes up, distributes, and gets rid of daridorexant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4 treatment arms in 2 sequences, ABCD or BACD.
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Daridorexant | Experimental | Drug: DaridorexantSingle dose of 50 mg daridorexant |
| Treatment B: Famotidine & daridorexant | Experimental | Drug: Daridorexant, Drug: FamotidineSingle dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant |
| Treatment C: Efavirenz | Experimental | Drug: Efavirenz600 mg efavirenz once daily in the evening from Day 5 to Day 14 |
| Treatment D: Daridorexant & efavirenz | Experimental | Drug: Daridorexant, Drug: EfavirenzSingle dose of 50 mg daridorexant in the morning of Day 15 followed by a single dose of 600 mg efavirenz in the evening of Days 15 and 16 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Healthy male subjects aged between 18 and 45 years (inclusive) at Screening.
Key exclusion criteria (7 listed)
- Clinically relevant findings on the physical examination at Screening.
- Clinically relevant abnormalities on 12-lead ECG, measured after at least 5 min in a supine position at Screening.
- Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry) at Screening and on Day -1.
- 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(s) (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.
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 will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions. | Drug | Treatment A: Daridorexant, Treatment B: Famotidine & daridorexant, Treatment D: Daridorexant & efavirenz |
| FamotidineFamotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions. | Drug | Treatment B: Famotidine & daridorexant |
| EfavirenzEfavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening. | Drug | Treatment C: Efavirenz, Treatment D: Daridorexant & efavirenz |
Primary outcome
PK parameter of daridorexant: Maximum plasma concentration (Cmax)
Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: Time to reach Cmax (tmax)
Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: AUC from zero to infinity (AUC0-inf)
Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: AUC from zero to 48 hours (AUC0-48)
Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: Terminal elimination half-life (t½)
Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).
1 secondary outcome
Treatment-emergent (S)AEs
Time frame: Up to EOP for each of the Periods 1 to 3 and up to EOS for Period 4 (Total duration: up to 3 months)
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.
- 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
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, Famotidine and Efavirenz in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
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 2 inclusion and 7 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 Germany. 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?
PK parameter of daridorexant: Maximum plasma concentration (Cmax) (time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).). The study lists 5 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 Sep 2020.