Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatic Impairment
- Nalbuphine
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: This is a Phase 1, open-label PK and safety study of NAL ER in subjects with impaired liver function compared to healthy subjects. It will be performed in 2 parts: Part 1: single-ascending-dose (SAD) cohorts Part 2: multiple-ascending-dose (MAD) cohort In Part 1 (SAD)-Dose Cohorts 1-5: Each of the cohorts will be dosed sequentially starting with the lowest dose. The drug kinetics in the hepatic impairment subject population will be compared relative to the healthy subject population (Cohort 5). Part 2 (MAD) - Dose Cohort 6: 6-8 subjects with mild hepatic impairment and 6-8 subjects with moderate hepatic impairment In Part 2 of the study (MAD), subjects will receive multiple doses ascending from 27 mg up to 162 mg over 13 days of dosing.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
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 ...
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
Tracking Information
- NCT #
- NCT04020016
- Collaborators
- Syneos Health
- Investigators
- Study Director: Thomas Sciascia Trevi Therapeutics, Inc.
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