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Does breakfast change how this pain drug works? new study investigates

NCT ID NCT07487740

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This early-stage trial is testing whether eating a high-fat, high-calorie meal changes how the body absorbs nalbuphine extended-release tablets. Sixty healthy volunteers will take the drug once with food and once without, and researchers will compare drug levels in their blood. The study is not designed to treat any condition, but to gather information for future use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nalbuphine extended-release tablets

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

60 people

The number who actually took part.

Started

Feb 2026

Finished

May 2026

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/m2) 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) at Screening or check-in (Day -1). * History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing. * Positive urine drug or alcohol results at Screening or check in (Day -1). * Smoker who has smoked or used nicotine containing products within the last 3 months prior to the first dose and throughout the study, confirmed by a negative cotinine test at Screening and check-in (Day -1). * 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 corrected QT (QTc) interval. * Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). * Participation in another clinical study within 5 half-lives or 30 days, whichever is longer, 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, LLC.

    Miami, Florida, 33172, United States

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