Single-dose PK Assessment of Oral Proglumide in Those Wit... | NCT04814602

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

NCT04814602

Sponsor

Georgetown University

Status

Completed

Last Update Posted

Mar 15, 2022Actual

Enrollment

11Actual

Phase

Early Phase 1

Conditions

Cirrhosis, Liver

Interventions

Proglumide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2021Actual

Primary Completion Date

Aug 30, 2021Actual

Completion Date

Feb 20, 2022Actual

First Submitted Date

Mar 22, 2021

First Submission Date that Met QC Criteria

Mar 22, 2021

First Posted Date

Mar 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2022

Last Update Posted Date

Mar 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Proglumide	Drug	CCK receptor antagonist	Control Hepatic Impaired

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proglumide blood levels in hepatic impaired subjects	Proglumide levels in ng/ml in cirrhosis subjects compared to healthy controls	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Urinary excretion of proglumide	Measurement of proglumide in urine after single does ingestion in cirrhosis compared to healthy controls	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jill P Smith, MD	Georgetown University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown University		Washington D.C.	District of Columbia	20007	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Will be published and placed on clinicaltrials website

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Apr 4, 2022
Reset	Oct 12, 2022
Release	Feb 22, 2023
Reset	Dec 4, 2023
Release	Dec 10, 2023
Reset	May 24, 2024
Release	Dec 23, 2025
Reset	Jan 13, 2026

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011377	Proglumide

Ancestor Terms

ID	Term
D005973	Glutamine
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 4, 2022			Oct 12, 2022
Feb 22, 2023