NCT04020016

Study of Nalbuphine ER in Participants With Hepatic Impairment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Trevi Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Nalbuphine ER	Oral tablet

Timeline

• Start date: 2019-06-12
• Primary completion: 2020-02-05
• Completion: 2020-02-05
• First posted: 2019-07-15
• Last updated: 2026-03-19
• Results posted: 2026-03-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study