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

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.

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