Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trevi Therapeutics
• Collaborator: Syneos Health
• Treatments: Nalbuphine

Criteria

Inclusion Criteria:

For Subjects 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

Inclusion Criteria:

For Healthy Subjects (Cohort 5):

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

• Healthy as defined by:

1. Normal hepatic function

2. The absence of clinically significant illness and surgery within 4 weeks prior to dosing.

Exclusion Criteria:

For Subjects 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 subject by participation in the study.

Exclusion Criteria

For Healthy Subjects (Cohort 5):

• Diagnosis of liver disease

• History of heart problems.

• History of significant alcohol abuse or drug abuse