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Altered Drug Disposition and Biomarkers for Diagnosis of Chronic Inflammatory Liver Disease

NCT01766960 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-03-03

No results posted yet for this 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.

Conditions

Interventions

OTHER

High fat meal

A high fat breakfast will be administered to induce gall bladder emptying.

DRUG

Morphine

Five milligrams of intravenous morphine will be administered.

Sponsors & Collaborators

  • University of North Carolina, Greensboro

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Alfred S Barritt, MD · University of North Carolina, Chapel Hill

  • Kim LR Brouwer, PharmD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-03-31
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01766960 on ClinicalTrials.gov