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NCT05392530
A Study of Two Different Test Formulations Compared to the Reference Formulation of Macitentan in Healthy Adult Participants
Phase 1 trial testing Macitentan in Healthy in 23 participants. Completed in 14 September 2022.
30 August 2022
Quick facts
| Lead sponsor | Actelion |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 23 |
| Start date | 25 May 2022 |
| Primary completion | 30 August 2022 |
| Estimated completion | 14 September 2022 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Macitentan (MACITENTAN) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Actelion — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the rate and extent of absorption of a single oral dose of macitentan given as 2 test formulations compared to the reference formulation under fed conditions in healthy adult participants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05392530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Macitentan
Trials testing the same drug.
- NCT05731492 — A Study of Macitentan in Children Below 2 Years of Age · Phase 1 · withdrawn
- NCT05167825 — A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension · Phase 3 · completed
- NCT05433675 — A Study of Two Macitentan Formulations in Healthy Adult Participants · Phase 1 · completed
- NCT05373108 — Endothelin-1 and Cardiac Allograft Vasculopathy (CAV) · Phase 4 · completed
- NCT05179876 — A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no O · Phase 3 · recruiting
Other recruiting trials for Healthy
Currently open trials in the same condition.
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- 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 Actelion trials
Trials by the same sponsor.
- NCT05731492 — A Study of Macitentan in Children Below 2 Years of Age · Phase 1 · withdrawn
- NCT05433675 — A Study of Two Macitentan Formulations in Healthy Adult Participants · Phase 1 · completed
- NCT05427162 — A Study of Single and Multiple Doses of Different Formulations of a Prostacyclin Receptor Agonist · Phase 1 · completed
- NCT05179876 — A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no O · Phase 3 · recruiting
- NCT05236231 — A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Ma · 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 NCT05392530 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Actelion
- Last refreshed: 30 March 2025
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/NCT05392530.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing