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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: Completed Phase 1 study, sponsored by Trevi Therapeutics.
NCT04020016 is a Phase 1 study that has completed, run by Trevi Therapeutics. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT04020016 record still lists
NCT04020016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Nalbuphine ER is the first listed.
NCT04020016 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04020016's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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