Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch
Status:
Active, not recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
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.