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Hepatic ImpairmentPhase 1NCT04020016

Study of Nalbuphine ER in Participants With Hepatic Impairment

A Phase 1 study testing Nalbuphine ER in people with Hepatic Impairment, run by Trevi Therapeutics at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study will evaluate the effect of hepatic impairment on the pharmacokinetics (the breakdown of the drug in the body) of parallel-group, multiple oral doses nalbuphine extended release (NAL ER), tablets in people with hepatic impairment (mild, moderate and severe), compared to people with normal liver… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment
What is being tested?
Nalbuphine ER
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesUnited States
Study dates
12 Jun 2019to 5 Feb 2020
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • Healthy as defined by:
  • Normal hepatic function
  • The absence of clinically significant illness and surgery within 4 weeks prior to dosing.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • 01

    Miami, Florida, 33136

  • 02

    Miami, Florida, 33146

  • 03

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Non-Randomized, Parallel-Group, Multiple-Escalating-Dose Pharmacokinetic Study of Nalbuphine Extended-Release Oral Tablets in Subjects With Impaired Hepatic Function Compared to Healthy Subjects and Exploratory Effect on Itch

This research study will evaluate the effect of hepatic impairment on the pharmacokinetics (the breakdown of the drug in the body) of parallel-group, multiple oral doses nalbuphine extended release (NAL ER), tablets in people with hepatic impairment (mild, moderate and severe), compared to people with normal liver function. The study will also test the safety and tolerability of the NAL ER, when it is given to participants with mild, moderate and severe hepatic impairment, compared to participants with normal liver function. This protocol will also study the effects of this drug on itching in hepatic impairment participants if they report some itching prior to taking part in this study.

Being tested
Nalbuphine ER
Keywords
nalbuphine, Pharmacokinetic, hepatic impairment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nalbuphine ERDrug

    Also called NAL ER

    Oral tablet

Study groups in NCT04020016
Study groupRoleWhat they receive
Part 1 Single Ascending DoseExperimentalParticipants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose ranging from 27 mg up to 162 mg of NAL ER tablet under fasting conditions. There was a washout period of at least 7 days between the drug administration between each dose level. Participants with no hepatic impairment (group 4) received a single dose of NAL ER of up to 162 mg under fasting conditions.
Receives: Drug: Nalbuphine ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER

    Measured: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level

  2. Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER

    Measured: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level

  3. Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER

    Measured: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level

  4. Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER

    Measured: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level

  5. Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER

    Measured: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level

  6. Part 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)

    An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was defined as any AE that occurs after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.

    Measured: From signing the informed consent form up to Day 4

  7. Part 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

    The clinical laboratory parameters included the clinical chemistry, hematology, coagulation, and urinalysis. Clinical significance was determined by the investigator.

    Measured: From signing the informed consent form up to Day 4

  8. Part 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters

    Vital signs measurements included diastolic and systolic blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.

    Measured: From signing the informed consent form up to Day 4

  9. Part 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters

    Physical examination included examination of at least the following components: head, eyes, ears, nose, throat (HEENT), neck, lungs, abdomen, skin, cardiovascular and musculoskeletal evaluation, and general neurological examination. Clinical significance was determined by the investigator.

    Measured: From signing the informed consent form up to Day 4

  10. Part 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)

    ECG data included the measurement of heart rate and aggregate PR interval, QRS duration, QT interval, QTcB interval, and QTcF interval.

    Measured: From signing the informed consent form up to Day 4

  11. Part 1: Number of Participants With Clinically Significant Findings in Pulse Oximetry

    Oxygen saturation was measured via pulse oximetry. Pulse oximetry measurements were to be collected within 10 min before or after the specified time point. Clinical significance was determined by the investigator.

    Measured: Pre-dose and 1.5, 4, 5, and 8 hours post-dose in each dose level

Secondary outcomes (1)

  1. Part 2: Change From Baseline in Worst Itch Numerical Rating Scale (WI-NRS)

    WI-NRS measure was used determine the severity of itch experienced by participants with hepatic impairment (for Cohort 6 only) at screening. Participants were to complete the two forms (the "Night-time Itch" and the "Daytime Itch") at the same time during the screening visit and the average was taken to determine the baseline severity. The scale was a 0 to 10 rating scale with 10 being the most severe itch experienced and 0 being no itching experienced. Higher score indicated greater severity of itching.

    Measured: Baseline, Day 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2019
  2. Study start12 Jun 2019
  3. Primary completion5 Feb 2020
  4. Study completion5 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04020016
Sponsor's protocol ID
Protocol 182018 (TR10)
Status last verified
Feb 2026
First submitted
30 May 2019
Last updated
19 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nalbuphine ER in people with Hepatic Impairment, run by Trevi Therapeutics at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER (time frame: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04020016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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