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NCT01766960 · ClinicalTrials.gov registry record · Phase 1
Altered Drug Disposition and Biomarkers for Diagnosis of Chronic Inflammatory Liver Disease
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01766960: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT01766960 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01766960, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
One-third of the U.S. population suffers from non-alcoholic fatty liver disease (NAFLD). NAFLD is caused by diabetes and obesity, and is becoming more common. Although many people have this disease, the change in how the liver handles drugs and compounds in the body has not been studied. The purpose of this study is to investigate how advanced NAFLD changes the ability of the liver to handle both endogenous and exogenous compounds.
Primary Outcome
Morphine will be administered as a 5-min IV infusion. Pharmacokinetic profiles of morphine and morphine metabolites will be quantified in the serum over the 8-hour sampling period. Non-compartmental analysis will be performed using Pharsight Phoenix software, comparing the following parameters between healthy subjects and patients with advanced NAFLD. The maximal concentration, time of maximal concentration, elimination half-life, area under the curve, and systemic and renal clearances will be c
Interventions
- DRUG Morphine
- OTHER High fat meal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT01766960 record still lists
NCT01766960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Morphine is the first listed.
NCT01766960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01766960 about?
NCT01766960 is a clinical study titled "Altered Drug Disposition and Biomarkers for Diagnosis of Chronic Inflammatory Liver Disease". One-third of the U.S. population suffers from non-alcoholic fatty liver disease (NAFLD). NAFLD is caused by diabetes and obesity, and is becoming more common. Although many people have this disease, the change in how the liver handles drugs and compounds in the body has not been studied. The purpose...
What is the current status of trial NCT01766960?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2012-11. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01766960?
The interventions under investigation include: Morphine (DRUG), High fat meal (OTHER).
Who is sponsoring clinical trial NCT01766960?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01766960's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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