Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04020016 · ClinicalTrials.gov registry record · Phase 1
Study of Nalbuphine ER in Participants With Hepatic Impairment
A Phase 1 study, sponsored by Trevi Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT04020016 is a Phase 1 study that has completed, run by Trevi Therapeutics. The registered enrollment target is 28 participants.
The verdict
NCT04020016, a Phase 1 study, has completed, sponsored by Trevi Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Nalbuphine ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2020-02-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04020016
The ClinicalTrials.gov registry entry for NCT04020016 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Trevi Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nalbuphine ER is the first listed.
NCT04020016 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04020016 about?
NCT04020016 is a clinical study titled "Study of Nalbuphine ER in Participants With Hepatic Impairment". 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 wi...
What is the current status of trial NCT04020016?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2019-06-12. Estimated completion is 2020-02-05.
What interventions are being tested in trial NCT04020016?
The interventions under investigation include: Nalbuphine ER (DRUG).
Who is sponsoring clinical trial NCT04020016?
This trial is sponsored by Trevi Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.