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DMID 13-0053 for Patients with NASH and Healthy Volunteers - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn how people with cirrhosis respond to a new antibiotic compared to healthy people.

What is the Condition Being Studied?

Liver cirrhosis

Who Can Participate in the Study?

Adults (age 18-70) with liver cirrhosis and healthy volunteers who:
- Do not smoke or smoke less than 10 cigarettes per day
- Do not have HIV
- Have not donated blood in the past 30 days
- Do not currently abuse drugs or alcohol

Age Group
Adults

What is Involved?

If you choose to join the study you will:
- Have a screening visit that will last about 3 hours.
- Be randomized, like the flip of a coin, to one of two groups:
-- One group will receive the study antibiotic OR
-- One group will receive a placebo (an inactive substance)
- Have a 3 day (2 night) inpatient stay in the hospital
- Have 4 follow-up outpatient visits that will last about 1 hour each.  
-- Have blood drawn at each visit.
- Have ECGs, vital signs, and physical exams performed several times throughout the study.  

Study Details

Full Title
A Phase I, Single Dose, Open-label, Sequential Group Study Comparing the Pharmacokinetics and Safety of PA-824 in Subjects with Mild, Moderate, and Severe Hepatic Impairment to Matched, Non-Hepatically Impaired Subjects
Principal Investigator
Gastroenterologist
Protocol Number
IRB:PRO00062544
NCT:NCT02422524
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698