A Scintigraphy Study in Adults With Diabetic Gastroparesis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind Placebo-Controlled Scintigraphy Study to Investigate the Effect of CIN-102 on Gastric Emptying and Antral Contractility in Adults With Diabetic Gastroparesis

Conditions
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Diabetic Gastroparesis

Intervention / Treatment
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* Drug: CIN-102 Dose 1
* Drug: CIN-102 Dose 2
* Drug: Placebo for CIN-102


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIN-102 Tablets Dose 1<br>CIN-102 tablets by mouth twice daily for 14 days | Drug: CIN-102 Dose 1<br>* Deuterated domperidone (deudomperidone)<br>|
| Placebo Comparator: Placebo for CIN-102 Dose 1<br>Placebo tablets by mouth twice daily for 14 days | Drug: Placebo for CIN-102<br>* Placebo<br>|
| Experimental: CIN-102 Dose 2<br>CIN-102 tablets by mouth twice daily for 14 days | Drug: CIN-102 Dose 2<br>* Deuterated domperidone (deudomperidone)<br>|
| Placebo Comparator: Placebo for CIN-102 Dose 2<br>Placebo tablets by mouth twice daily for 14 days | Drug: Placebo for CIN-102<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Change From Baseline in Gastric Percentage Retention of a Radiolabeled Meal After Dosing CIN-102 in Patients With Diabetic Gastroparesis. |  | Baseline to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Incidence of Treatment-emergent Adverse Effects as Measured by Safety Laboratory Data and Patient Reported Events. |  | Screening to Day 20 | 
| To Assess the Effect of CIN-102 on Antral Contractility as Measured by Dynamic Antral Scintigraphy (DAS), a Non-invasive Technique for the Assessment of Post-prandial Gastric Contractions Will be Used to Evaluate Antral Motility. |  | Baseline to Day 14 | 
| To Assess the Effect of CIN-102 on Gastric Accommodation to be Evaluated Using Data Captured During the Total-stomach Gastric Emptying Study to Measure Food Retention in the Stomach During the First Two Post-prandial Hours. |  | Baseline to Day 14 | 
| To Asses the Change From Baseline in ANMS GCSI-DD Total Scores |  | Day -14 to 14 | 
| To Assess the Change From Baseline in ANMS GCSI-DD Subscale Scores |  | Day -14 to 14 | 
| To Assess the Change From Baseline in Symptom Severity as Measured by the PAGI-SYM |  | Baseline to Day 14 | 
| To Assess the Change in Baseline of the Clinical Grading Assessment Scale |  | Baseline to Day 14 |