Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04020016
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2019-05-30
Brief Title:
Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch
Sponsor:
Trevi Therapeutics
Organization:
Trevi Therapeutics
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None