Single-dose PK Assessment of Oral Proglumide in Those With Hepatic Impairment
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Proglumide is an oral cholecystokinin (CCK) receptor antagonist that has been shown in
non-clinical studies to reverse hepatic fibrosis and decrease the incidence of hepatocellular
carcinoma (HCC). Because of these potential beneficial properties, proglumide may be useful
in decreasing the fibrosis and risk for HCC in those with cirrhosis. Although proglumide is
safe in those with normal hepatic function, the pharmacokinetics have not been established in
those that are hepatic impaired. The purpose of this study is to analyze proglumide blood
levels and excretion in subjects with cirrhosis compared to health controls.