← Back to Search

Opioid Analgesic

Part 1 Single Ascending Dose for Nalbuphine

Phase 1
Waitlist Available
Research Sponsored by Trevi Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -1 to day 16
Awards & highlights

Study 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.

Eligible Conditions
  • Nalbuphine
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -1 to day 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -1 to day 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events as assessed by Pulse Oximetry and Electrocardiogram (ECG)
Individual and mean plasma concentrations verses time curves will be evaluated as a function of dose
Secondary outcome measures
Worst Itch Numerical Rating Scale (WI-NRS) measurement tool for rating of itch severity in the hepatic impaired population

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 Multiple Ascending DoseExperimental Treatment1 Intervention
Impaired liver function subjects will receive multiple ascending dosing up to 162 mg BID of Nalbuphine ER
Group II: Part 1 Single Ascending DoseExperimental Treatment1 Intervention
Impaired liver function subjects and healthy liver subjects single ascending dosing up to 162 mg BID of Nalbuphine ER

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Trevi TherapeuticsLead Sponsor
10 Previous Clinical Trials
1,331 Total Patients Enrolled
2 Trials studying Nalbuphine
98 Patients Enrolled for Nalbuphine
Syneos HealthOTHER
172 Previous Clinical Trials
68,398 Total Patients Enrolled
1 Trials studying Nalbuphine
56 Patients Enrolled for Nalbuphine
Thomas SciasciaStudy DirectorTrevi Therapeutics, Inc.
3 Previous Clinical Trials
126 Total Patients Enrolled
1 Trials studying Nalbuphine
42 Patients Enrolled for Nalbuphine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch
2018. "Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04020016.
All > Liver Disease
~9 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top