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Healthy volunteers help test drug combo safety

NCT ID NCT07015398

Knowledge-focused Sponsor: Trevi Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a long-acting painkiller (nalbuphine ER) affects and is affected by two lung fibrosis drugs (pirfenidone and nintedanib) in 132 healthy adults. Researchers measured drug levels in the blood and monitored for side effects. The goal was to see if these drugs can be safely taken together.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

132 people

The number who actually took part.

Started

Jun 2025

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m\^2) at Screening. * Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee. Exclusion Criteria: * Positive results for coronavirus infection (COVID-19). * History or presence of alcohol or drug abuse. * Positive urine drug or alcohol results. * Smoker who has used nicotine containing products within the last 3 months. * History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds. * Hemoglobin, absolute neutrophil count, or platelet levels outside of the reference range at Screening. * History of prolonged QT syndrome or a QTc interval. * Abnormal liver function at Screening or historical or concurrent liver disease. * Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). * Abnormal Estimated glomerular filtration rate (eGFR). * History of difficulty donating blood or donation of blood or plasma within 56 days of Screening. * Participation in another clinical study within 30 days of the baseline visit. \[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.\]

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy participants

Contacts and locations

Locations

  • Clinical Pharmacology of Miami

    Miami, Florida, 33172, United States

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