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NCT03586570
A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects
Phase 1 trial testing Aprocitentan 25mg in Healthy Subjects in 20 participants. Completed in 10 September 2018.
10 September 2018
Quick facts
| Lead sponsor | Idorsia Pharmaceuticals Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 17 July 2018 |
| Primary completion | 10 September 2018 |
| Estimated completion | 10 September 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Aprocitentan 25mg — full drug profile →
- Placebo
Conditions studied
- Healthy Subjects — all drugs for Healthy Subjects →
Sponsor
Idorsia Pharmaceuticals Ltd. — full company profile →
Who can join
Adults 20 to 45, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Current Knowledge About Aprocitentan in Hypertension.
Bank-Mikkelsen EM, Grimm D, Wehland M. · · 2025 · PMID 41373585 · DOI 10.3390/ijms262311431
Verify or expand the search:
- PubMed search for NCT03586570
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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)
- Trial protocol + status: ClinicalTrials.gov NCT03586570 (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: 23 November 2022
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/NCT03586570.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing