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Effect of Non-Alcoholic Steatohepatitis (NASH) on the Pharmacokinetics of 99mTechnetium-Mebrofenin

NCT02235233 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-05-05

No results posted yet for this study

Summary

This study is designed to investigate the effect of NASH (non-alcoholic steatohepatitis) on the disposition of 99mTechnetium(Tc)-mebrofenin and to relate changes in 99mTc-mebrofenin disposition to differences in the bile acid profile and Fibroscan Fibrosis Score of healthy subjects compared to patients with NASH.

Conditions

  • Non-alcoholic Steatohepatitis

Interventions

DRUG

Technetium Tc 99M Mebrofenin

Each subject will be injected with \~2.5 mCi of Technetium Tc 99M Mebrofenin

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Sidney Barritt, M.D., MSCR · University of North Carolina, Chapel Hill

  • Jason R. Slizgi, B.S. · UNC School of Pharmacy

  • Kim Brouwer, PharmD, PhD · UNC School of Pharmacy

  • Josh Kaullen, Pharm.D. · UNC School of Pharmacy

  • Marijia Ivanovic, Ph.D. · UNC Department of Radiology

  • Paul Stewart, Ph.D. · UNC School of Public Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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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 NCT02235233 on ClinicalTrials.gov