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Guanylyl Cyclase C Agonist

Plecanatide + Linaclotide for Digestive Health

Phase 1
Recruiting
Led By David S Weinberg
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Must not have
History of gastric bypass, gastric sleeve, or bariatric surgery
Prior treatment in the past week with plecanatide, linaclotide, or other agent whose primary mechanism of action is that of a GCC agonist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at the effects of taking either plecanatide or linaclotide on a chemical in the small intestine, and how they compare to not taking either drug.

Who is the study for?
This trial is for adults over 18 who are not pregnant or breastfeeding, agree to use contraception, and have an ECOG performance status of <=1. They must be scheduled for an esophagogastroduodenoscopy (EGD), willing to provide biospecimens, and haven't used GCC agonists or investigational agents recently.
What is being tested?
The study examines the effects of two FDA-approved constipation drugs, plecanatide or linaclotide, on a chemical in duodenal tissue from the small intestine compared to no drug treatment. Participants will undergo biospecimen collection including biopsy during EGD.
What are the potential side effects?
While specific side effects aren't listed here, plecanatide and linaclotide can generally cause diarrhea, abdominal pain, swelling or bloating. Allergic reactions may occur if sensitive to similar compounds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on long-term antiviral treatment for herpes.
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I can take care of myself and perform daily activities.
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I am 18 years old or older.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My hepatitis B virus load is undetectable with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had weight loss surgery in the past.
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I have not taken plecanatide, linaclotide, or similar drugs in the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cyclic guanosine monophosphate (cGMP) levels
Other study objectives
Cellular response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (linaclotide, EGD)Experimental Treatment4 Interventions
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.
Group II: Arm I (plecanatide, EGD)Experimental Treatment4 Interventions
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.
Group III: Arm III (EGD)Active Control3 Interventions
Patients undergo standard of care EGD with biopsy and luminal fluid collection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Esophagogastroduodenoscopy
2017
Completed Phase 3
~1240
Linaclotide
2008
Completed Phase 4
~9200
Plecanatide
2016
Completed Phase 3
~10840

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,017 Total Patients Enrolled
David S WeinbergPrincipal InvestigatorFox Chase Cancer Center
2 Previous Clinical Trials
4,633 Total Patients Enrolled

Media Library

Linaclotide (Guanylyl Cyclase C Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05107219 — Phase 1
Acid Reflux Research Study Groups: Arm II (linaclotide, EGD), Arm I (plecanatide, EGD), Arm III (EGD)
Acid Reflux Clinical Trial 2023: Linaclotide Highlights & Side Effects. Trial Name: NCT05107219 — Phase 1
Linaclotide (Guanylyl Cyclase C Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05107219 — Phase 1
~3 spots leftby Feb 2025
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