NCT03799978 is a Phase 1 clinical trial of ACT-541468 in Healthy, sponsored by Idorsia Pharmaceuticals Ltd..

Who is sponsoring NCT03799978?

NCT03799978 is sponsored by Idorsia Pharmaceuticals Ltd..

What drugs are being tested in NCT03799978?

Interventions in NCT03799978: ACT-541468.

Is NCT03799978 still recruiting?

NCT03799978 is currently completed. Last updated 12 April 2019.

Last reviewed 2019-04-12 · How we verify

NCT03799978

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

A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects

Completed Phase 1 Last updated 12 April 2019

What this trial tests

Phase 1 trial testing ACT-541468 in Healthy in 20 participants. Completed in 18 March 2019.

Timeline

9 March 2019

Primary endpoint
18 March 2019

18 March 2019

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	20
Start date	9 March 2019
Primary completion	18 March 2019
Estimated completion	18 March 2019
Sites	1 location across Czechia

Drugs / interventions tested

ACT-541468 — 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

This is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.

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 ACT-541468

Trials testing the same drug.

NCT04024332 — Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Co · Phase 1 · completed
NCT03892902 — A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderl · Phase 1 · completed
NCT03765294 — A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obs · Phase 1 · completed
NCT03646864 — A Study to Evaluate the Effects of ACT-541468 on Respiration in Patients With Moderate Chronic Obstructive Pulmonary Dis · Phase 1 · completed
NCT03657355 — Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users · 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 NCT03799978 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 12 April 2019

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/NCT03799978.

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