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NCT03657446
A Study in Healthy Subjects to Investigate Whether Administration of Clazosentan Can Affect Normal Heart Function
Phase 1 trial testing Clazosentan in Healthy Subjects in 36 participants. Completed in 26 October 2018.
26 October 2018
Quick facts
| Lead sponsor | Idorsia Pharmaceuticals Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 36 |
| Start date | 18 September 2018 |
| Primary completion | 26 October 2018 |
| Estimated completion | 26 October 2018 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Clazosentan (CLAZOSENTAN) — full drug profile →
- Placebo
- Moxifloxacin (moxifloxacin) — full drug profile →
Conditions studied
- Healthy Subjects — all drugs for Healthy Subjects →
Sponsor
Idorsia Pharmaceuticals Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
PK/PD modeling of a clazosentan thorough QT study with hysteresis in concentration-QT and RR-QT.
Henrich A, Juif PE, Dingemanse J, Krause A. · · 2021 · cited 4× · PMID 33389549 · DOI 10.1007/s10928-020-09728-7
Verify or expand the search:
- PubMed search for NCT03657446
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Clazosentan
Trials testing the same drug.
- NCT03585270 — Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the · Phase 3 · completed
- NCT03596294 — A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan · Phase 1 · completed
- NCT02560532 — Evaluation of the Efficacy and Safety of Clazosentan in Reversing Cerebral Vasospasm in Adult Subjects With Aneurysmal S · Phase 2 · completed
- NCT00558311 — Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachno · Phase 3 · completed
Other recruiting trials for Healthy Subjects
Currently open trials in the same condition.
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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 NCT03657446 (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: 20 November 2018
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/NCT03657446.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing