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.
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER
Timeframe: 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
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER
Timeframe: 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
Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER
Timeframe: 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
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER
Timeframe: 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
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER
Timeframe: 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
Part 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
Timeframe: From signing the informed consent form up to Day 4
Part 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Timeframe: From signing the informed consent form up to Day 4
Part 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters
Timeframe: From signing the informed consent form up to Day 4
Part 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters
Timeframe: From signing the informed consent form up to Day 4
Part 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)
Timeframe: From signing the informed consent form up to Day 4
Part 1: Number of Participants With Clinically Significant Findings in Pulse Oximetry
Timeframe: Pre-dose and 1.5, 4, 5, and 8 hours post-dose in each dose level