Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05428150 · ClinicalTrials.gov registry record · Phase 1
Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers
A Phase 1 study of Idiopathic Pulmonary Fibrosis, sponsored by Excalibur Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT05428150: Completed Phase 1 study of Idiopathic Pulmonary Fibrosis, sponsored by Excalibur Pharmaceuticals.
NCT05428150 is a Phase 1 study of Idiopathic Pulmonary Fibrosis that has completed, run by Excalibur Pharmaceuticals. The registered enrollment target is 32 participants, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05428150, a Phase 1 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by Excalibur Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, open-label, 2-treatment, 2-period, crossover steady state study conducted to evaluate the comparative bioavailability/bioequivalence of pirfenidone after multi-dose administration of EXCL-100 at doses of 1200 mg (600 mg x 2) in the fed state, and Esbriet® 801 mg (267 mg capsule x 3) given in the fed state, to healthy volunteers.
Primary Outcome
Area under plasma concentration-time curve from time 0 to infinity for pirfenidone and 5-carboxy pirfenidone
Conditions Studied
Interventions
- DRUG Esbriet 267 MG Oral Capsule
- DRUG EXCL-100, 600 MG Oral Tablet
Study Locations (1)
Ohio
- Medpace Clinical Pharmacology Unit - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-08-08 |
| Est. Completion | 2022-09-25 |
| Phase | Phase 1 |
What the finished NCT05428150 record still lists
NCT05428150 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Esbriet 267 MG Oral Capsule is the first listed.
NCT05428150 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05428150 about?
NCT05428150 is a clinical study titled "Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers". This is a randomized, open-label, 2-treatment, 2-period, crossover steady state study conducted to evaluate the comparative bioavailability/bioequivalence of pirfenidone after multi-dose administration of EXCL-100 at doses of 1200 mg (600 mg x 2) in the fed state, and Esbriet® 801 mg (267 mg capsule...
What is the current status of trial NCT05428150?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-08-08. Estimated completion is 2022-09-25.
What conditions does trial NCT05428150 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis.
What interventions are being tested in trial NCT05428150?
The interventions under investigation include: Esbriet 267 MG Oral Capsule (DRUG), EXCL-100, 600 MG Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05428150?
This trial is sponsored by Excalibur Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05428150 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05428150's enrollment target sits among peer trials
32 39th of 51 higher than 12 of 51 other Idiopathic Pulmonary Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis 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
-
Dose-Escalation Study of Artesunate Patients With IPF
RECRUITING · Phase 1
-
Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
RECRUITING · Phase 1
-
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants
RECRUITING · Phase 1
-
NAL ER IPF Respiratory Function and Safety Study
RECRUITING · Phase 1
-
Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
RECRUITING · Phase 1
-
Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients
ACTIVE NOT RECRUITING · Phase 1
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
- NCT02445781 · 32 participants · Early Phase 1
Differing Levels of Hypoglycemia
- NCT02792270 · 32 participants · NA
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
- NCT03068910 · 32 participants · Early Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
- NCT03208868 · 32 participants · NA
Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis
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