Study of Nalbuphine ER in Participants With Hepatic Impairment

Trevi Therapeutics

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Nalbuphine ER

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04020016

Protocol 182018 (TR10)

Details and patient eligibility

About

This research study will evaluate the effect of hepatic impairment 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 hepatic impairment (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 participants with mild, moderate and severe hepatic impairment, compared to participants with normal liver function. This protocol will also study the effects of this drug on itching in hepatic impairment participants if they report some itching prior to taking part in this study.

Enrollment: 28 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For participants with Hepatic Impairment (Cohort 1 to 4 and Cohort 6):

• Male or female with stable hepatic impairment, non-smoker and/or light smoker.
• Clinical diagnosis of liver cirrhosis
• Stable for study participation based upon medical history, physical examination, vital signs, ECGs, and screening clinical laboratory evaluations

For Healthy participants (Cohort 5):

• Male or female, non-smoker and/or light smoker (up to 5 cigarettes or equivalent/day)

• Healthy as defined by:

  • Normal hepatic function
  • The absence of clinically significant illness and surgery within 4 weeks prior to dosing.

Exclusion criteria

For participants with Hepatic Impairment (Cohort 1 to 4 and Cohort 6):

• Clinically significant unstable medical conditions
• Clinically significant abnormalities of laboratory, ECG, pulse oximetry, or clinical data that would preclude participation in the study.
• History of any illness that might confound the results of the study or pose an additional risk to the participant by participation in the study.

For Healthy participants (Cohort 5):

• Diagnosis of liver disease
• History of heart problems.
• History of significant alcohol abuse or drug abuse

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Part 1 Single Ascending Dose

Experimental group

Description:

Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose ranging from 27 mg up to 162 mg of NAL ER tablet under fasting conditions. There was a washout period of at least 7 days between the drug administration between each dose level. Participants with no hepatic impairment (group 4) received a single dose of NAL ER of up to 162 mg under fasting conditions.

Treatment:

Drug: Nalbuphine ER