“Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch”
This research study will evaluate the effect of liver disease 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 liver disease (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 subjects with mild, moderate and severe liver disease, compared to subjects with normal liver function. This protocol will also study the effects of this drug on itching in liver disease subjects if they report some itching prior to taking part in this study.
Drug - Nalbuphine ER
Cohort 1: 6-8 subjects will receive 1 dose of 27mg and observed for 4 days. Cohort 2: 6-7 subjects will receive 1 dose of 54 mg and observed for 4 days. Cohort 3: 6-7 subjects will receive 1 dose of 108 mg and observed for 4 days. Cohort 4: 6-8 subjects will receive 1 dose of 162 mg and observed for 4 days. Cohort 5: 6-8 healthy subjects will receive dosing of NAL ER and observed for 4 days.
Drug - Nalbuphine ER -
Cohort 6: â€¢ 6-8 subjects with mild hepatic impairment and 6-8 subjects with moderate hepatic impairment. Doses will be subsequently escalated for each subject starting at 27 mg on Day 1 to twice daily, 12 hours apart, 27 mg, 54 mg, 108 mg, and 162 mg over 13 days.
A Study of Nalbuphine Extended-release (NAL ER) Oral Tablets in Subjects With Impaired Hepatic Function Compared to Healthy Subjects and Exploratory Effect on Itch