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

NCT05270460 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PCS12852-GP-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 9

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.

Conditions

Gastroparesis

Keywords

Idiopathic Gastroparesis; Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (6)

• Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate

  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.

  ~28 days

• Change in Gastric Emptying Rate From Baseline Using t50 Metric for Gastric Emptying Rate

  Time for 50% gastric emptying (t50) metric assessed by the GEBT

  ~28 days

• Concentrations of PCS12852 in Plasma - Cmax

  PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.

  Day 1

• Concentrations of PCS12852 in Plasma - AUC0-last

  PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.

  Day 1

• Concentrations of PCS12852 in Plasma - AUC0-last

  PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.

  Day 28

• Concentrations of PCS12852 in Plasma - Cmax

  PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.

  Day 28

Secondary Outcomes (4)

• Change From Baseline in the ANMS GCSI-DD

  Day 7

• Change From Baseline in the ANMS GCSI-DD

  Day 14

• Change From Baseline in the ANMS GCSI-DD

  Day 21

• Change From Baseline in the ANMS GCSI-DD

  Day 28

Study Arms (3)

PCS12852 0.1mg

EXPERIMENTAL

PCS12852 0.1mg tablet

Drug: PCS12852

PCS12852 0.5mg

EXPERIMENTAL

PCS12852 0.5mg tablet

Drug: PCS12852

Placebo

PLACEBO COMPARATOR

Similar in appearance to active study drug

Drug: Placebo

Interventions

PCS12852 DRUG

PCS12852 oral tablet administered once daily

PCS12852 0.1mg; PCS12852 0.5mg

Placebo DRUG

Placebo comparator oral tablet administered once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Processa Pharmaceuticals: lead

Study Sites (9)

Torrance Clinical Research Institute, Inc.

Lomita, California, 90717, United States

Location

TriWest Research Associates

San Diego, California, 92108, United States

Location

APF Research, LLC

Miami, Florida, 33135, United States

Location

International Research Associates, LLC

Miami, Florida, 33183, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Delta Research Partners

Bastrop, Louisiana, 71220, United States

Location

Long Island Gastrointestinal Research Group

Great Neck, New York, 11023, United States

Location

M3 Wake Research

Raleigh, North Carolina, 27612, United States

Location

Texas Tech University

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sian Bigora
• Organization: Processa Pharmaceuticals Inc.

sbigora@processapharmaceuticals.com

410-693-6844

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 8, 2022
• Study Start: March 9, 2022
• Primary Completion: September 29, 2022
• Study Completion: October 6, 2022
• Last Updated: July 21, 2023
• Results First Posted: July 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)