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NCT07015398 · ClinicalTrials.gov registry record · Phase 1
A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants
A Phase 1 study, sponsored by Trevi Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
NCT07015398: Completed Phase 1 study, sponsored by Trevi Therapeutics.
NCT07015398 is a Phase 1 study that has completed, run by Trevi Therapeutics. The registered enrollment target is 132 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07015398, a Phase 1 study, has completed, sponsored by Trevi Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the effect of steady-state NAL ER on the pharmacokinetics (PK) of pirfenidone or nintedanib and the effect of steady-state pirfenidone or nintedanib on the PK of NAL ER in healthy participants.
Interventions
- DRUG NAL ER
- DRUG Pirfenidone
- DRUG Nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2025-06-30 |
| Est. Completion | 2025-09-26 |
| Phase | Phase 1 |
What the finished NCT07015398 record still lists
NCT07015398 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (120% higher).
The record links to 0 conditions, and to 3 interventions - of which NAL ER is the first listed.
NCT07015398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07015398 about?
NCT07015398 is a clinical study titled "A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants". The primary purpose of this study is to evaluate the effect of steady-state NAL ER on the pharmacokinetics (PK) of pirfenidone or nintedanib and the effect of steady-state pirfenidone or nintedanib on the PK of NAL ER in healthy participants.
What is the current status of trial NCT07015398?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2025-06-30. Estimated completion is 2025-09-26.
What interventions are being tested in trial NCT07015398?
The interventions under investigation include: NAL ER (DRUG), Pirfenidone (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT07015398?
This trial is sponsored by Trevi Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07015398's enrollment target sits among peer trials
132 432nd of 2000 higher than 1,562 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
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