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NCT01846455 · ClinicalTrials.gov registry record · Phase 4
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
A Phase 4 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
NCT01846455: Completed Phase 4 study, sponsored by Indivior.
NCT01846455 is a Phase 4 study that has completed, run by Indivior. The registered enrollment target is 43 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01846455, a Phase 4 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
Study Summary
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
Primary Outcome
AUC0-last was calculated for buprenorphine, norbuprenorphine, naloxone, and naloxone-3-β-D-glucuronide using non-compartmental analysis: AUC0-last = AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule.
Interventions
- DRUG Promethazine
- DRUG 2.0mg Buprenorphine/0.5mg Naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
What the finished NCT01846455 record still lists
NCT01846455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Promethazine is the first listed.
NCT01846455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01846455 about?
NCT01846455 is a clinical study titled "Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects". The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
What is the current status of trial NCT01846455?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2012-09. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01846455?
The interventions under investigation include: Promethazine (DRUG), 2.0mg Buprenorphine/0.5mg Naloxone (DRUG).
Who is sponsoring clinical trial NCT01846455?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01846455's enrollment target sits among peer trials
43 1371st of 2000 higher than 621 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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