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Liver function may affect how itch drug works in body

NCT ID NCT04020016

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study looked at how the body breaks down nalbuphine extended-release tablets in people with mild, moderate, or severe liver impairment compared to healthy volunteers. It also explored whether the drug could relieve itching in those with liver problems. The study involved 28 participants and focused on safety and drug levels in the blood.

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

28 people

The number who actually took part.

Started

Jun 2019

Finished

Feb 2020

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 80 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: For participants with Hepatic Impairment (Cohort 1 to 4 and Cohort 6): * Male or female with stable hepatic impairment, non-smoker and/or light smoker. * Clinical diagnosis of liver cirrhosis * Stable for study participation based upon medical history, physical examination, vital signs, ECGs, and screening clinical laboratory evaluations For Healthy participants (Cohort 5): * Male or female, non-smoker and/or light smoker (up to 5 cigarettes or equivalent/day) * Healthy as defined by: * Normal hepatic function * The absence of clinically significant illness and surgery within 4 weeks prior to dosing. Exclusion Criteria: For participants with Hepatic Impairment (Cohort 1 to 4 and Cohort 6): * Clinically significant unstable medical conditions * Clinically significant abnormalities of laboratory, ECG, pulse oximetry, or clinical data that would preclude participation in the study. * History of any illness that might confound the results of the study or pose an additional risk to the participant by participation in the study. For Healthy participants (Cohort 5): * Diagnosis of liver disease * History of heart problems. * History of significant alcohol abuse or drug abuse

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver liver disorder

As listed by the trial registrant

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

Hepatic impairment

Contacts and locations

Locations

  • 01

    Miami, Florida, 33136, United States

  • 02

    Miami, Florida, 33146, United States

  • 03

    Orlando, Florida, 32809, United States

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