Single-dose PK Assessment of Oral Proglumide in Those With Hepatic Impairment

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Georgetown University
• Treatments: Proglumide

Criteria

Inclusion Criteria:

• Cirrhosis previously confirmed by one of the following: Liver biopsy, FibroScan, FibroSure, MR-Elastography, or nodular liver on radiographic imaging like CT or MRI. Child-Pugh classification A (N=4) and Child-Pugh classification B (N=4)

Exclusion Criteria:

• Those that are Child-Pugh classification C cirrhosis

• gastrointestinal bleeding from esophageal varices within 6 months

• Chronic kidney disease with Estimated glomerular filtration rate (eGFR of < 90 mL/min/1.73m2)

• hepatic encephalopathy

• those that have had an organ transplant

• active hepatitis C, active hepatitis B, and those with HIV disease

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Pregnant women

• Prisoners