NCT04390334 is a Phase 1 clinical trial of Daridorexant in Healthy, sponsored by Idorsia Pharmaceuticals Ltd..

Who is sponsoring NCT04390334?

NCT04390334 is sponsored by Idorsia Pharmaceuticals Ltd..

What drugs are being tested in NCT04390334?

Interventions in NCT04390334: Daridorexant, Famotidine, Efavirenz.

Is NCT04390334 still recruiting?

NCT04390334 is currently completed. Last updated 16 September 2020.

Last reviewed 2020-09-16 · How we verify

NCT04390334

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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.

Completed Phase 1 Last updated 16 September 2020

What this trial tests

Phase 1 trial testing Daridorexant in Healthy in 24 participants. Completed in 26 June 2020.

Timeline

13 May 2020

Primary endpoint
26 June 2020

26 June 2020

Quick facts

Lead sponsor	Idorsia Pharmaceuticals Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	24
Start date	13 May 2020
Primary completion	26 June 2020
Estimated completion	26 June 2020
Sites	1 location across Germany

Drugs / interventions tested

Daridorexant (DARIDOREXANT) — full drug profile →
Famotidine (famotidine) — full drug profile →
Efavirenz (EFAVIRENZ) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Idorsia Pharmaceuticals Ltd. — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Daridorexant: First Approval.
Markham A. · · 2022 · cited 45× · PMID 35298826 · DOI 10.1007/s40265-022-01699-y
Daridorexant, a Recently Approved Dual Orexin Receptor Antagonists (DORA) in Treatment of Insomnia.
Sarathi Chakraborty D, Choudhury S, Lahiry S. · · 2023 · cited 8× · PMID 37425970 · DOI 10.1055/s-0043-1770805

Verify or expand the search:

Other trials of Daridorexant

Trials testing the same drug.

NCT07028697 — A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder · Phase 3 · completed
NCT06326723 — Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects · Phase 1 · completed
NCT06010693 — A Study of Daridorexant in Chinese Patients With Insomnia Disorder · Phase 3 · completed
NCT05597020 — A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia · Phase 4 · completed
NCT05632393 — A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women · Phase 1 · completed

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Idorsia Pharmaceuticals Ltd. trials

Trials by the same sponsor.

NCT06799884 — A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormo · Phase 1 · completed
NCT05877222 — A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in · Phase 1 · completed
NCT05597020 — A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia · Phase 4 · completed
NCT05632393 — A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women · Phase 1 · completed
NCT05702177 — A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04390334 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Idorsia Pharmaceuticals Ltd.
Last refreshed: 16 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04390334.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing