A Scintigraphy Study in Adults With Diabetic Gastroparesis

NCT ID: NCT04208698

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2020-03-31

Brief Summary

This is a randomized, double-blind, placebo-controlled scintigraphy study to investigate the effect of oral CIN-102 on gastric emptying and antral contractility in adults with diabetic gastroparesis.

Detailed Description

This is a randomized, double-blind, placebo-controlled scintigraphy study to investigate the effect of oral CIN-102 on gastric emptying and antral contractility in adults with diabetic gastroparesis. The population for this study is adult patients 18 to 70 years old with Type 1 or Type 2 diabetes and a diagnosis of diabetic gastroparesis. The study will consist of two cohorts with approximately 15 subjects in each cohort.

Conditions

Diabetic Gastroparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CIN-102 Tablets Dose 1

CIN-102 tablets by mouth twice daily for 14 days

Group Type: EXPERIMENTAL

CIN-102 Dose 1

Intervention Type: DRUG

Deuterated domperidone (deudomperidone)

Placebo for CIN-102 Dose 1

Placebo tablets by mouth twice daily for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo for CIN-102

Intervention Type: DRUG

Placebo

CIN-102 Dose 2

CIN-102 tablets by mouth twice daily for 14 days

Group Type: EXPERIMENTAL

CIN-102 Dose 2

Intervention Type: DRUG

Deuterated domperidone (deudomperidone)

Placebo for CIN-102 Dose 2

Placebo tablets by mouth twice daily for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo for CIN-102

Intervention Type: DRUG

Placebo

Interventions

CIN-102 Dose 1

Deuterated domperidone (deudomperidone)

Intervention Type: DRUG

CIN-102 Dose 2

Deuterated domperidone (deudomperidone)

Intervention Type: DRUG

Placebo for CIN-102

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female patients 18 to 70 years old, inclusive.
• Type 1 or Type 2 diabetes mellitus, according to American Diabetes Association criteria
• Current diagnosis of diabetic gastroparesis.
• Body Mass Index (BMI) between 18 and 40 kg/m2, inclusive.
• Glycosylated hemoglobin level <11% at Screening.
• Willing to abstain from tobacco or nicotine-containing product use after midnight on the day of the DAS test and throughout the time that gastric emptying is being imaged.
• Willing to abstain from grapefruit, grapefruit products, star fruit, star fruit products, and Seville oranges from 72 hours prior to the Randomization Visit until end of study.

Exclusion Criteria

• History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, atrial fibrillation, and Torsades de Pointes. Patients with minor forms of ectopy (eg, premature atrial contractions) are not necessarily excluded.
• Clinically significant bradycardia with a resting heart rate under 50 beats per minute, sinus node dysfunction, or heart block.
• Prolonged heart rate-corrected QT interval using Fridericia's formula (QTcF) (QTcF >450 msec for males or QTcF >470 msec for females) based on the average of triplicate ECGs.
• A personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias or family history of sudden death.
• Evidence (based on Screening or Baseline assessments) or history of clinically significant immunologic, hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies); surgical conditions; cancer (with the exception of basal or squamous cell carcinoma of the skin and cancer that resolved or has been in remission for >5 years prior to the Screening Visit); or any condition that, in the Investigator's opinion, might significantly interfere with the absorption, distribution, metabolism, or excretion of the study drug.
• History of prolactin-releasing pituitary tumor (ie, prolactinoma).
• Allergic to egg or intolerant to gluten.
• History of alcoholism or drug abuse within 2 years prior to dosing as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition.
• Known or suspected gastric outlet obstruction (eg, peptic stricture) or other gastrointestinal mechanical obstruction.
• Known history or current diagnosis of intestinal malabsorption or pancreatic exocrine disease.
• History or presence of any medical condition or psychiatric disease, which, in the opinion of the Investigator, could interfere with the conduct of the study or would put the patient at unacceptable risk.
• Judged by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluation, to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of the study outcomes.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CinDome Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Murphy, MD, MPH

Role: STUDY_DIRECTOR

CinRx Pharma

Locations

Research Site

El Paso, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CIN-102-122

Identifier Type: -

Identifier Source: org_study_id