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

NCT04814602 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 3464
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• Proglumide blood levels in hepatic impaired subjects

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

  24 hours

Secondary Outcomes (1)

• Urinary excretion of proglumide

  24 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

Healthy controls Proglumide 400 mg given once by mouth

Drug: Proglumide

Hepatic Impaired

EXPERIMENTAL

Cirrhosis Child-Pugh A and B Proglumide 400 mg given once by mouth

Drug: Proglumide

Interventions

Proglumide DRUG

CCK receptor antagonist

Also known as: Milid

Control; Hepatic Impaired

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University

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

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Proglumide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glutamine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino

Study Officials

• Jill P Smith, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open labeled

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: March 30, 2021
• Primary Completion: August 30, 2021
• Study Completion: February 20, 2022
• Last Updated: March 15, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)