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NCT03657355
Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users
Completed
Phase 1
Last updated 19 September 2019
What this trial tests
Phase 1 trial testing ACT-541468 in Healthy Recreational Drug Users in 63 participants. Completed in 8 August 2019.
Timeline
7 September 2018
Primary endpoint
8 August 2019
8 August 2019
8 August 2019
Quick facts
| Lead sponsor | Idorsia Pharmaceuticals Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 63 |
| Start date | 7 September 2018 |
| Primary completion | 8 August 2019 |
| Estimated completion | 8 August 2019 |
| Sites | 2 locations across Canada, United States |
Drugs / interventions tested
- ACT-541468 — full drug profile →
- Suvorexant — full drug profile →
- Zolpidem (zolpidem) — full drug profile →
- Placebo
Conditions studied
- Healthy Recreational Drug Users — all drugs for Healthy Recreational Drug Users →
Sponsor
Idorsia Pharmaceuticals Ltd. — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Recreational Drug Users. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users
Publications & conference data
7 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 -
Repurposing the dual orexin receptor antagonist suvorexant for the treatment of opioid use disorder: why sleep on this any longer?
James MH, Fragale JE, Aurora RN, Cooperman NA, et al · · 2020 · cited 43× · PMID 31986520 · DOI 10.1038/s41386-020-0619-x -
Abuse potential assessment of the new dual orexin receptor antagonist daridorexant in recreational sedative drug users as compared to suvorexant and zolpidem.
Ufer M, Kelsh D, Schoedel KA, Dingemanse J. · · 2022 · cited 29× · PMID 34480579 · DOI 10.1093/sleep/zsab224 -
Opioid Use Disorder, Sleep Deficiency, and Ventilatory Control: Bidirectional Mechanisms and Therapeutic Targets.
Eckert DJ, Yaggi HK. · · 2022 · cited 18× · PMID 35649170 · DOI 10.1164/rccm.202108-2014ci -
Sleep Deficiency and Opioid Use Disorder: Trajectory, Mechanisms, and Interventions.
Langstengel J, Yaggi HK. · · 2022 · cited 17× · PMID 35659031 · DOI 10.1016/j.ccm.2022.05.001 -
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 -
Daridorexant for the treatment of insomnia disorder: A systematic review and meta-analysis of randomized controlled trials.
Jiang F, Li H, Chen Y, Lu H, et al · · 2023 · cited 6× · PMID 36800596 · DOI 10.1097/md.0000000000032754
Verify or expand the search:
- PubMed search for NCT03657355
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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
- 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
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 NCT03657355 (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: 19 September 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/NCT03657355.
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