A Phase 2A, Placebo-controlled, Randomized, Dose Response Study of the Safety, Pharmacokinetics and Efficacy of PCS12852 on Gastric Emptying Rate Assessed by 13C Spirulina GEBT in Patients With Moderate to Severe Gastroparesis
Overview
- Phase
- Phase 2
- Intervention
- PCS12852
- Conditions
- Gastroparesis
- Sponsor
- Processa Pharmaceuticals
- Enrollment
- 25
- Locations
- 9
- Primary Endpoint
- Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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-
- •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.
Arms & Interventions
PCS12852 0.5mg
PCS12852 0.5mg tablet
Intervention: PCS12852
Placebo
Similar in appearance to active study drug
Intervention: Placebo
PCS12852 0.1mg
PCS12852 0.1mg tablet
Intervention: PCS12852
Outcomes
Primary Outcomes
Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate
Time Frame: ~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
Time Frame: ~28 days
Time for 50% gastric emptying (t50) metric assessed by the GEBT
Concentrations of PCS12852 in Plasma - Cmax
Time Frame: Day 28
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Concentrations of PCS12852 in Plasma - AUC0-last
Time Frame: Day 28
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Secondary Outcomes
- Change From Baseline in the ANMS GCSI-DD(Day 28)