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NCT Number: NCT04020016

Study of Nalbuphine ER in Participants With Hepatic Impairment

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.

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Key information

Conditions

Hepatic Impairment

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

01, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nalbuphine ER

Drug

Oral tablet

Other names: NAL ER

Primary outcomes

  1. 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

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

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

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

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

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

    Time frame: From signing the informed consent form up to Day 4

    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.

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

    Time frame: From signing the informed consent form up to Day 4

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

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

    Time frame: From signing the informed consent form up to Day 4

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

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

    Time frame: From signing the informed consent form up to Day 4

    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.

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

    Time frame: From signing the informed consent form up to Day 4

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

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

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

    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.

Secondary outcomes

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

    Time frame: Baseline, Day 16

    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.

Sponsors and collaborators

Lead sponsor

Trevi Therapeutics

Industry

Collaborators

  • Syneos Health

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2019
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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