The main reason for this study is to see how the study drug interacts with the body. It will compare different doses of the study drug with a drug already in use. Participants will be adults with liver disease that has affected the brain in the past.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Southern California Research Center
Coronado, California, United States
Inland Empire Clinical Trials
Rialto, California, United States
Global Clinical Professionals
St. Petersburg, Florida, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
Ammonia Plasma Levels at Baseline and Day 5
This test measures the level of ammonia in your blood. Ammonia, also known as NH3, is a waste product made by your body during the digestion of protein. Normally, ammonia is processed in the liver, where it is changed into another waste product called urea. Urea is passed from the body in urine. If your body cannot process or eliminate ammonia, a lab test of a blood sample shows it has built up in the bloodstream. High ammonia levels in the blood can lead to serious health problems, including hepatic encephalopathy.
Time frame: Baseline, Day 5
Number of Participants With Adverse Events by the End of the Trial
End of trial is defined as 7 (+/-3) days after last study treatment
Time frame: within 15 days
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Fundacion de Investigacion (Research Foundation)
San Juan, Puerto Rico