Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis

Phase 2

Completed

• Conditions: Gastroparesis
• Interventions: Drug: PCS12852; Drug: Placebo

• Registration Number: NCT05270460
• Lead Sponsor: Processa Pharmaceuticals

Brief Summary

This is a randomized, double-blind, placebo-controlled study that will compare the effect of 2 different dosage regimens of PCS12852 on gastric emptying time to placebo in both idiopathic gastroparesis (IG) and diabetic gastroparesis (DG) patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-08
• Study Start: 2022-03-09
• Primary Completion: 2022-09-29
• Study Completion: 2022-10-06
• Results First Submitted: 2023-05-22
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-28
• Last Update Submitted: 2023-06-28
• Results First Posted: 2023-07-21
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Has documented diagnosis of moderate to severe DG or IG according to the ANMS GCSI-DD score during the Screening period (score of >2 on average of the screening days).
• Moderate to severe delay in gastric emptying rate as measured by the GEBT at Screening defined as GE half-time (t1/2) ≥ the 80th percentile of normative data as determined by Cairn Diagnostics.
• Male or female patients 18 to 80 years of age, inclusive, at baseline.
• Has continuous moderate to severe symptoms for gastroparesis (that is, chronic postprandial fullness, abdominal pain, postprandial nausea, vomiting, loss of appetite and/or early satiety) as assessed by the investigator for at least the past 3 months.
• Has hemoglobin A1c (BbA1c) < 11%.
• Has Body Mass Index range between 18-40.
• Women of childbearing potential must use one of the following acceptable methods of contraception throughout the study (1 month prior to Screening through 1 month after last dose of study medication): oral contraceptive medication, IUD, hormonal implants, injectable contraceptive methods, double-barrier methods, or tubal ligation.
• Male patients must be willing to use acceptable contraceptive measures such as vasectomy or double-barrier method and refrain from sexual activity with any female who is pregnant or lactating. Female partners of study participants are asked to use acceptable methods of contraception.

Exclusion Criteria

• Has acute, severe gastroenteritis and pronounced dehydration in the past 48 hours prior to Screening, chronic parenteral feeding or persistent severe vomiting.
• Has known hypersensitivity to Spirulina, egg, milk products or wheat allergens.
• Has a known disturbance of small intestinal absorption, exocrine pancreatic function, liver metabolism or pulmonary function.
• Has a history of anorexia nervosa or bulimia.
• Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
• Prior surgery involving any gastrointestinal surgery, including the luminal gastrointestinal (GI) tract (cholecystectomy and appendectomy are permitted if performed >3 months prior to baseline GEBT).
• Any abdominal or pelvic surgery within the past 3 months.
• Known history of the following GI conditions: inflammatory bowel disease; irritable bowel syndrome with diarrhea; or any other active disorder that could explain symptoms in the opinion of the investigator.
• Has active diverticulitis, diverticular stricture, and other intestinal strictures.
• Currently taking Glucagon-like peptide-1 (GLP-1) agonists, e.g. exenatide, liraglutide, semaglutide or dulaglutide, or pramlintide.
• Has severe psychiatric illness (including suicidal tendencies or ideation) or neurological illness.
• Use of narcotics/opioids, drugs used to treat gastroparesis within 3 days of the Screening GEBT test.
• Clinically significant cardiac disease including but not limited to unstable angina, acute myocardial infarction within 6 months of baseline, and arrhythmia requiring therapy.
• Patient has QTc interval ≥ 480 milliseconds on Screening ECG.
• History of cerebral hemorrhage, cerebrovascular accident, transient ischemic attack, gastrointestinal bleeding, or retinal hemorrhage within 6 months of baseline.
• Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within the past 5 years prior to baseline.
• Presence of clinically significant medical condition(s) including but not limited to: renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, neurological, psychiatric, substance abuse, and or any other clinically significant disease or disorder, which in the opinion of the investigator, may put the patient at risk due to participation in the study, influence the results of the study, and/or affect the patient's ability to complete the study.
• History of or current diagnosis of active tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of the Screening Visit of a positive TB skin test with purified protein derivative with induration ≥ 5 mm, a positive QuantiFERON TB test or positive or borderline T-SPOT [Elispot] test); or positive TB test at Screening. Patients with documented completion of appropriate LTBI treatment would not be excluded and are not required to be tested.
• Currently taking known P-gp and BCRP inhibitors or inducers and gastric acid reducing agents. E.g., proton pump inhibitors or H2 receptor antagonists.

Other inclusion/exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCS12852 0.1mg	PCS12852	PCS12852 0.1mg tablet
PCS12852 0.5mg	PCS12852	PCS12852 0.5mg tablet
Placebo	Placebo	Similar in appearance to active study drug

Primary Outcome Measures

Name	Time	Method
Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate	~28 days	Change from baseline in gastric emptying rate was determined by the AUC by Gastric Emptying Breath Test (GEBT) at Day 28 after administration of PCS12852 or placebo.
Change in Gastric Emptying Rate From Baseline Using t50 Metric for Gastric Emptying Rate	~28 days	Time for 50% gastric emptying (t50) metric assessed by the GEBT
Concentrations of PCS12852 in Plasma - Cmax	Day 28	PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Concentrations of PCS12852 in Plasma - AUC0-last	Day 28	PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the ANMS GCSI-DD	Day 28	Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary. Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.

Trial Locations

Locations (9)

Long Island Gastrointestinal Research Group; 🇺🇸 Great Neck, New York, United States

APF Research, LLC; 🇺🇸 Miami, Florida, United States

Torrance Clinical Research Institute, Inc.; 🇺🇸 Lomita, California, United States

Delta Research Partners; 🇺🇸 Bastrop, Louisiana, United States

M3 Wake Research; 🇺🇸 Raleigh, North Carolina, United States

TriWest Research Associates; 🇺🇸 San Diego, California, United States

International Research Associates, LLC; 🇺🇸 Miami, Florida, United States

Texas Tech University; 🇺🇸 El Paso, Texas, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States