Oral Capsule

BID

AEs will be coded using the MedDRA coding dictionary. An AE is defined as any untoward medical occurrence in a clinical investigation subject that does not necessarily have causal relationship with treatment. AEs will further be categorized by severity, relationship to study medication, and action taken. All AEs will be presented in data listings for subjects.

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a semi-structured clinical interview designed to systematically assess and track suicidal adverse events (behavior and ideation) throughout different settings including clinical trials. Results from the C-SSRS will be listed for each subject. These data will also be summarized for all subjects for suicidal ideation events, suicidal behaviors, and completed suicides.

Vital sign measurements include oral temperature (C), respiratory rate, semi-supine blood pressure (systolic and diastolic) (mmHg) and semi-supine heart rate (bpm). Criteria for identifying vital signs as Potentially Clinically Notable Abnormalities are based on the Guidelines for the Division of Neuropharmacological Drug Products. Data from vital signs will be listed, clinically notable values will be flagged, and other information collected will be listed. Data will also be summarized using mean change from first study visit and proportion of subjects with values outside the normal range, and values that were clinically notable.

Variables include PR (ms), QRS (ms), QTc (ms), and Heart Rate (bpm). Note: ms = millisecond; bpm = beats per minute

Laboratory data will be summarized by presenting the proportions of patients with clinically notable abnormalities as follows: shift tables, first study visit to most extreme post-treatment value, using normal ranges; summary statistics of raw data and change from first study visit values (means, medians, standard deviations, ranges). Criteria for identifying laboratory values as Potentially Clinically Notable Abnormalities are based on the FDA's Guidelines for the Division of Neuropharmacological Drug Products.

Efficacy is assessed by the Gastroparesis Core Symptom Daily Diary (GCSDD). The GCSDD is a daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe). Other symptoms include vomiting, postprandial fullness, early satiety, and abdominal pain.