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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 is a Phase 1 study that has completed, run by Trevi Therapeutics. The registered enrollment target is 132 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07015398
The ClinicalTrials.gov registry entry for NCT07015398 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Trevi Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which NAL ER is the first listed.
NCT07015398 reports 0 study locations.
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.
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