A Scintigraphy Study in Adults With Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Intervention: CIN-102 Dose 1; CIN-102 Dose 2; Placebo for CIN-102
Intervention description: Deuterated domperidone (deudomperidone); Deuterated domperidone (deudomperidone); Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

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.