Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04235270 · ClinicalTrials.gov registry record · Phase 1
A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT04235270: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT04235270 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04235270, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic (PK) parameters of tadalafil administered as an fixed dose combination (FDC) (test) of macitentan/tadalafil (10 milligram \[mg\]/40 mg) and coadministered as a free combination (reference) of 10 mg macitentan (Opsumit) and 40 mg Canada-sourced tadalafil (Adcirca) in fasted conditions in healthy adult participants (Group 1) and to evaluate the effect of food on the primary PK parameters of macitentan and tadalafil administered as an FDC of macitentan/tadalafil (10 mg/40 mg) in healthy adult participants (Group 2).
Primary Outcome
Cmax is the maximum observed plasma analyte concentration.
Interventions
- DRUG Tadalafil
- DRUG Macitentan
- COMBINATION_PRODUCT FDC of Macitentan and Tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2020-01-17 |
| Est. Completion | 2020-07-17 |
| Phase | Phase 1 |
What the finished NCT04235270 record still lists
NCT04235270 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Tadalafil is the first listed.
NCT04235270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04235270 about?
NCT04235270 is a clinical study titled "A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants". The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic (PK) parameters of tadalafil administered as an fixed dose combination (FDC) (test) of macitentan/tadalafil (10 milligram \[mg\]/40 mg) and coadministered as a free combination (reference) of 10 mg macitentan (...
What is the current status of trial NCT04235270?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2020-01-17. Estimated completion is 2020-07-17.
What interventions are being tested in trial NCT04235270?
The interventions under investigation include: Tadalafil (DRUG), Macitentan (DRUG), FDC of Macitentan and Tadalafil (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04235270?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04235270's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03231150 · 62 participants · NA
Plantar Fasciitis Randomized Clinical Control Trial
- NCT03458676 · 62 participants · NA
Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies
- NCT03596086 · 62 participants · Phase 1
HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
- NCT03603405 · 62 participants · Phase 1
HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI