Healthy Clinical Trial
Official title:
Aminotransferase Trends During Prolonged Therapeutic Acetaminophen Dosing
The objective of this study is to monitor liver function tests (blood levels of an indicator
of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen
compared to people taking placebo for 16 to 40 days. Those people that continue to have
normal liver tests after 16 days will have completed their part of the study. People that
develop abnormal liver function tests will continue taking acetaminophen or placebo, and
have their liver tests monitored closely for up to an additional 24 days. This is to (1)
make sure these tests return to normal and (2) determine when these tests return to normal
while still taking acetaminophen or placebo. If at any time the liver tests indicate
anything more than a minor increase, you would be immediately told to stop taking the study
drug.
Secondary objective is to determine the proportion of subjects that have detectable
acetaminophen-protein adducts after daily dosing.
Acetaminophen use is common and many consumers take 4g/day for longer than 4 days. The use of 4g/day of acetaminophen for more than 4 days causes an asymptomatic ALT elevation in some people. This elevation most likely resolves while continuing treatment, but it is possible that some individuals may go on to develop clinical liver injury. By carefully following healthy subjects who are taking the maximal daily dose of acetaminophen, we can safely determine if the ALT elevation resolves or progresses to clinical liver injury. If a subject develops clinical liver injury we can intervene before irreversible injury occurs. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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