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CompletedNCT04390334Updated Sep 16, 2020

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 interventional study of Daridorexant and Famotidine in Healthy, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Idorsia Pharmaceuticals Ltd. is the lead sponsor of 102 studies on the registry; 5 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 9 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Treatment A: Daridorexant

    Single dose of 50 mg daridorexant

    Drug: Daridorexant

  • Experimental
    Treatment B: Famotidine & daridorexant

    Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant

    Drug: Daridorexant · Drug: Famotidine

  • Experimental
    Treatment C: Efavirenz

    600 mg efavirenz once daily in the evening from Day 5 to Day 14

    Drug: Efavirenz

  • Experimental
    Treatment D: Daridorexant & efavirenz

    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

    Drug: Daridorexant · Drug: Efavirenz

Interventions

  • DrugDaridorexant

    Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.

  • DrugFamotidine

    Famotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions.

  • DrugEfavirenz

    Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.

06

What researchers measure

Primary outcomes

  1. PK parameter of daridorexant: Maximum plasma concentration (Cmax)

    Time frame: Various time points during Treatment A through D (Total duration: up to 3 weeks).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Secondary outcomes

  1. 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)

07

Study locations

1 site
  • CRS Clinical Research Services Mannheim GmbH
    Mannheim, 68167, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04390334
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Responsible party
Sponsor
First posted
May 15, 2020
Start date
May 13, 2020
Primary completion
Jun 26, 2020
Completion
Jun 26, 2020
Last update
Sep 16, 2020

Study contacts

Clinical Trials Study Director
study director · Idorsia Pharmaceuticals Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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