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NCT Number: NCT04814602

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

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.

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Key information

Conditions

Cirrhosis, Liver Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

About this study

The purpose of this study is to measure blood levels of proglumide after a single oral dose (400 mg) over a period of time and compare the blood levels to those with normal hepatic function (N=4) to determine if there is delayed metabolism and clearance of proglumide in those with hepatic impairment (HI) (N=8). Eligible subjects will provide a baseline blood and urine sample prior to ingesting proglumide 400 mg po. Blood will be collected from an intravenous catheter after ingestion at the following intervals: 1 hr, 3 hrs, 5 hrs, 7 hrs and 24 hr (± 4-5 hours). After 3 hrs and 5 hrs subjects will provide a urine sample. Samples will be analyzed by Mass Spectometry. Proglumide blood and urine levels in ng/ml will be plotted over time and the Cmax (peak plasma concentration), Tmax (time to reach Cmax) and T1/2 (elimination half time) calculated for each subject and compared to that of 4 healthy controls.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proglumide

Drug

CCK receptor antagonist

Other names: Milid

Primary outcomes

  1. Proglumide blood levels in hepatic impaired subjects

    Time frame: 24 hours

    Proglumide levels in ng/ml in cirrhosis subjects compared to healthy controls

Secondary outcomes

  1. Urinary excretion of proglumide

    Time frame: 24 hours

    Measurement of proglumide in urine after single does ingestion in cirrhosis compared to healthy controls

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Official study title

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

Acronym: HIPK

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 24, 2021
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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