Hepatic Impairment Clinical Trial
Official title:
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
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.
The study is a three-center study that will include both a single-ascending-dose (SAD)
portion and a multiple-ascending dose (MAD) portion. The PK, safety, and tolerability of
single ascending doses (SAD) of NAL ER (4 dose levels) will be evaluated in subjects with
mild, moderate and severe hepatic impairment.
The purpose of the SAD will be to assess the safety and PK parameters of the given dose
levels in hepatic impaired subjects relative to a selected healthy subject control population
as part of the overall NAL ER development program. The SAD will also allow a better
understanding of the safety, tolerability and expected steady state PK characteristics in
mild and moderate hepatic impairment prior to undertaking safety and itch suppression
efficacy studies in this patient population.
In the MAD portion of this study, PK assessment will be carried out at steady state at each
respective dose level at steady state during the titration over 13 days up to the highest
planned therapeutic dose of 162 mg. It is well documented, in clinical practice and the
opiate literature, that gradually increasing the dose of drug with a structured titration can
reduce the frequency and severity of the expected AEs associated with initiation of therapy.
The NAL ER clinical program utilizes this type of structured titration strategy, starting
with once per day dosing at the 27 mg dose of NAL ER, and increasing the dose in a stepwise
manner over the next 13 days to the target investigational dose of 162 mg twice daily.
Pharmacokinetic steady state is reached
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