Phase 1
N=16
Study of Nalbuphine ER in Participants With Hepatic Impairment
Hepatic Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04020016 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER — 3.30; 7.67; 13.9; 18.7 nanogram per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nalbuphine ER (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trevi Therapeutics
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER |
3.30; 7.67; 13.9; 18.7; 10.9; 22.3 | — |
| PRIMARY Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER |
4.000; 5.000; 5.000; 7.000; 3.000; 5.000 | — |
| PRIMARY Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER |
7.83; 11.92; 8.80; 9.55; 7.97; 7.56 | — |
| PRIMARY Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER |
68.15; 141.56; 300.09; 356.12; 194.12; 396.03 | — |
| PRIMARY Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER |
40.82; 114.96; 250.97; 357.32; 180.63; 377.56 | — |
| PRIMARY Part 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE) |
3; 5; 9; 12; 5 | — |
| PRIMARY Part 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters |
0; 0; 0; 0; 0 | — |
| PRIMARY Part 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters |
0; 0; 0; 0; 0 | — |
| PRIMARY Part 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters |
0; 0; 0; 0; 0 | — |
| PRIMARY Part 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) |
0; 0; 0; 0; 0 | — |
| PRIMARY Part 1: Number of Participants With Clinically Significant Findings in Pulse Oximetry |
0; 0; 0; 0; 0 | — |
| SECONDARY Part 2: Change From Baseline in Worst Itch Numerical Rating Scale (WI-NRS) |
— | — |
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 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04020016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.