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Trial · Interventional

CompletedPhase 1Registry data

GCC Agonist Signal in the Small Intestine

NCTNCT05107219 (opens ClinicalTrials.gov in a new tab)Other idNCI-2021-11620Other idNCI-2021-11620Other idUWI21-06-01Other idUWI21-06-01

Overview

Status
Completed
Phase
Phase 1
Enrollment
43 participants (actual)
Sponsor
University of Wisconsin, Madison · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
30 Nov 2022
Primary completion
6 Feb 2026
Completion
6 Feb 2026
First posted
4 Nov 2021
Last update posted
7 Apr 2026
Conditions
Barrett Esophagus · Gastroesophageal Reflux Disease · Malignant Digestive System Neoplasm

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024202520262027
  1. Ph 1

    GCC Agonist Signal in the Small Intestine

    NCT05107219

    30 Nov 2022 to 6 Feb 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This early phase I trial studies the guanylyl cyclase C (GCC) agonist effect on cGMP signal in duodenal tissue. Plecanatide and linaclotide are drugs approved by the Food and Drug Administration for the treatment of conditions related to constipation. This trial aims to see the effects of taking either one of two drugs, plecanatide or linaclotide, or no drug, on a certain chemical found in the tissue collected from small intestine and how they compare.

Interventions

  • BiopsyProcedure
  • Biospecimen CollectionProcedure
  • EsophagogastroduodenoscopyProcedure
  • LinaclotideDrug
  • PlecanatideDrug

Arms3

  • Experimental

    Arm I (plecanatide, EGD)

    Patients receive a single dose of plecanatide (3 mg) PO 60-120 minutes prior to standard of care EGD with biopsy and luminal fluid collection.

  • Experimental

    Arm II (linaclotide, EGD)

    Patients receive a single dose of linaclotide (145 mcg) PO 60-120 minutes prior to standard of care EGD with biopsy and luminal fluid collection.

  • Active comparator

    Arm III (EGD)

    Patients undergo standard of care EGD with biopsy and luminal fluid collection.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Cyclic guanosine monophosphate (cGMP) levels

    Time frame · Up to 2 years

    Registry description

    Will compare cGMP levels measured in normal-appearing duodenal mucosa biopsy specimens from participants receiving linaclotide or plecanatide to cGMP levels in specimens from participants receiving no active treatment. Will evaluate the difference between the control and each treated arm in cGMP levels using two-tailed two-sample Student t-tests. If necessary, a log transformation or Wilcoxon rank-sum will be used, as appropriate.

Secondary outcomes(2)
  1. cGMP levels in luminal fluid

    Time frame · Up to 2 years

  2. Vasodilator-stimulated phosphoprotein (VASP) phosphorylation in normal appearing duodenal mucosa

    Time frame · Up to 2 years

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Scheduled for clinically indicated esophagogastroduodenoscopy (EGD) * Age \>= 18 years of age. Note: Because no dosing or adverse event (AE) data are currently available on the use of plecanatide or linaclotide in participants \< 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable * Willing to provide mandatory biospecimens as specified in the protocol * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Not pregnant or breastfeeding, as determined by pregnancy test prior to EGD procedure. Note: The effects of plecanatide and linaclotide on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 2 weeks after discontinuing study agent. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. Breastfeeding should be discontinued if the mother is treated with plecanatide or linaclotide * Ability to understand and the willingness to sign a written informed consent document * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible Exclusion Criteria: * Prior treatment in the past week with plecanatide, linaclotide, or other agent whose primary mechanism of action is that of a GCC agonist * History of allergic reactions attributed to compounds of similar chemical or biologic composition of plecanatide or linaclotide * Use of any other investigational agents =\< 12 weeks prior to registration * Uncontrolled intercurrent illness, or psychiatric illness/social situations that would limit compliance with study requirements * History of gastric bypass, gastric sleeve, or bariatric surgery

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