NCT03892902 is a Phase 1 clinical trial of ACT-541468 in Healthy, sponsored by Idorsia Pharmaceuticals Ltd..

Who is sponsoring NCT03892902?

NCT03892902 is sponsored by Idorsia Pharmaceuticals Ltd..

What drugs are being tested in NCT03892902?

Interventions in NCT03892902: ACT-541468, Zopiclone 7.5 mg, Placebo.

Is NCT03892902 still recruiting?

NCT03892902 is currently completed. Last updated 31 October 2019.

Last reviewed 2019-10-31 · How we verify

NCT03892902

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

A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects

Completed Phase 1 Last updated 31 October 2019

What this trial tests

Phase 1 trial testing ACT-541468 in Healthy in 56 participants. Completed in 10 October 2019.

Timeline

25 March 2019

Primary endpoint
10 October 2019

10 October 2019

Quick facts

Lead sponsor	Idorsia Pharmaceuticals Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	other
Enrollment	56
Start date	25 March 2019
Primary completion	10 October 2019
Estimated completion	10 October 2019
Sites	1 location across Netherlands

Drugs / interventions tested

ACT-541468 — full drug profile →
Zopiclone 7.5 mg — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Idorsia Pharmaceuticals Ltd. — full company profile →

Who can join

Adults 50 to 80, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A clinical study to assess next-day driving performance following evening administrations of ACT-541468 in middle-aged and elderly subjects

Publications & conference data

3 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
Driving Performance after Bedtime Administration of Daridorexant, Assessed in a Sensitive Simulator.
Muehlan C, Brooks S, Vaillant C, Meinel M, et al · · 2022 · cited 23× · PMID 35426136 · DOI 10.1002/cpt.2592
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
NCT03765294 — A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obs · Phase 1 · completed
NCT03799978 — A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects · 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 NCT03892902 (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: 31 October 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/NCT03892902.

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