A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Dose Response of Oral CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
Phase: PHASE2
Conditions: Gastroparesis
Sponsor: CinDome Pharma, Inc.

 
 
CLINICAL STUDY PROTOCOL 
 
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate 
the Safety, Efficacy, Pharmacokinetics, and Dose Response of Oral 
CIN-102 in Adults with Idiopathic and Diabetic Gastroparesis 
Investigational Product: CIN-102 
Protocol Number: CIN-102-121 
 
 
 
Sponsor: 
CinDome Pharma, Inc. 
5375 Medpace Way 
Cincinnati, OH 45227 
United States 
 
 
 
 
 
Version Number: 3.0 
Original Protocol: 19 May 2019 
Version 2.0, Amendment 1: 15 Aug 2019 
Version 3.0, Amendment 2: 13 Nov 2019 
 
 
Confidentiality Statement 
The information in this document is confidential and is not to be disclosed without the written 
consent of CinDome Pharma, Inc. except to the extent that disclosure would be required by law 
and for the purpose of evaluating and/or conducting a clinical study for CinDome Pharma, Inc. 
You are allowed to disclose the contents of this document only to your Institutional Review Board 
and study personnel directly involved with conducting this protocol. Persons to whom the 
information is disclosed must be informed that the information is confidential and proprietary to 
CinDome Pharma, Inc. and that it may not be further disclosed to third parties. 

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INVESTIGATOR AGREEMENT 
By signing below, I agree that: 
I have read this protocol. I approve this document and I agree that it contains all necessary details 
for carrying out the study as described. I will conduct this study in accordance with the design and 
specific provision of this protocol and will make a reasonable effort to complete the study within 
the time designated. I will provide copies of this protocol and access to all information furnished 
by CinDome Pharma, Inc. to study personnel under my supervision. I will discuss this material 
with them to ensure they are fully informed about the study product and study procedures. I will 
let them know that this information is confidential and proprietary to CinDome Pharma, Inc. and 
that it may not be further disclosed to third parties. I understand that the study may be terminated 
or enrollment suspended at any time by CinDome Pharma, Inc., with or without cause, or by me if 
it becomes necessary to protect the best interests of the study subjects. 
I agree to conduct this study in full accordance with Food and Drug Administration Regulations, 
Institutional Review Board/Ethic Committee Regulations and International Council for 
Harmonisation Guidelines for Good Clinical Practices. 
 
 
 
 
 
 
______________________________________________  
____________________ 
Investigator’s Signature 
 
 
 
 
 
Date 
 
 
 
______________________________________________ 
Investigator’s Printed Name 
 

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SYNOPSIS 
TITLE:  A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, 
Efficacy, Pharmacokinetics, and Dose Response of Oral CIN-102 in Adults with Idiopathic or 
Diabetic Gastroparesis 
PROTOCOL NUMBER:  CIN-102-121 
INVESTIGATIONAL PRODUCT:  CIN-102 
PHASE:  2A 
INDICATION:  Treatment and relief of symptoms associated with acute and recurrent 
gastroparesis 
OBJECTIVES: 
The objectives of this study are the following: 
• To evaluate the safety and tolerability of multiple doses of CIN-102 in subjects with idiopathic 
or diabetic gastroparesis 
• To evaluate the effect of multiple doses of CIN-102 on gastric emptying as measured by the 
gastric emptying breath test (GEBT) in subjects with idiopathic or diabetic gastroparesis 
• To characterize the pharmacokinetic (PK) of multiple doses of CIN-102 in subjects with 
idiopathic or diabetic gastroparesis 
The exploratory objectives of this study include the following: 
• To assess the effect of multiple doses of CIN-102 on nausea associated with gastroparesis 
based on the nausea score on the American Neurogastroenterology and Motility Society 
Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) 
• To assess the effect of multiple doses of CIN-102 on ANMS GCSI-DD scores (total and 
subscales) in subjects with idiopathic or diabetic gastroparesis 
• To assess the effect of multiple doses of CIN-102 on a variety of patient reported outcomes 
• To characterize exposure-response relationships of CIN-102 
POPULATION: 
The population for this study is adult subjects 18 to 70 years old with idiopathic gastroparesis or 
Type 1 or Type 2 diabetes mellitus, according to the American Diabetes Association criteria, and 
a diagnosis of  gastroparesis defined by upper gastrointestinal symptoms felt to be consistent with 
gastroparesis or previously documented delayed gastric emptying.  

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DOSAGE FORMS AND ROUTE OF ADMINISTRATION: 
All subjects will take a dose of blinded study drug (CIN-102 or placebo capsules) orally at 
AM 
 and 
PM 
 
 
 
 
 
 
 
 
 
 
On Day 14 [±2 days], all subjects will fast for a minimum of 8 hours before the morning dose of 
study drug and 4 hours following the completion of the GEBT meal. 
 
 Subjects will be provided study drug for self-
administration for doses not administered at the site. 
EFFICACY VARIABLES:  
The primary efficacy variable is the change from baseline (gathered on Days -10 to -3) in gastric 
emptying as measured by GEBT at Day 14 (±2 days).  
The GEBT is a nonradioactive stable isotope breath test, in which the ratio of exhaled 13CO2/12CO2 
is used to determine the rate of gastric emptying after consumption of a standardized, 13C-enriched 
meal. Subjects will consume a standardized, 13C-enriched meal after an 8-hour fast at baseline 
(Days -10 to -3) and after an 8-hour fast starting 30 minutes after study drug administration on 
Day 14 (±2 days). Breath samples will be obtained twice prior to consumption of a standardized, 
13C-enriched meal and then at 45, 90, 120, 150, 180, and 240 minutes after meal consumption after 
an 8-hour fast on Days -10 to -3 and Day 14 (±2 days) and 30 minutes after study drug 
administration on Day 14 (±2 days). 
The secondary efficacy variables are the following: 
• The change from baseline in gastric emptying as measured by GEBT BT T½ (BT T½ at Day 
14 (±2 days) 
 
 
 
 
 
 
 
 
 
 
 
 

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SAFETY VARIABLES: 
Safety of CIN-102 will be assessed by physical examinations, ECGs, vital sign assessments, 
clinical laboratory evaluations (including prolactin), and adverse events. 
STATISTICAL ANALYSES: 
The Intent-to-Treat Population will include all randomized subjects. 
The Modified Intent-to-Treat (MITT) Population will include all randomized subjects who receive 
at least 1 dose of study drug. 
The Per-Protocol (PP) Population will include all subjects in the MITT Population without major 
protocol violations. Reasons for excluding subjects from the PP Population will be defined and 
documented in the Statistical Analysis Plan. 
The PK Population will include all subjects who receive CIN-102 and have at least 1 quantifiable 
postdose plasma CIN-102 concentration.  
The PK Evaluable Population will include subjects who have sufficient plasma concentration data 
to characterize at least 1 PK parameter.  

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SAMPLE SIZE DETERMINATION: 
A total of approximately 60 subjects (15 subjects per treatment) will be randomized to 
CIN-102 
 BID, CIN-102 
 BID, CIN-102 
 BID, or placebo. The sample size is 
considered adequate to provide the necessary data to evaluate the objectives of the study. No 
formal statistical assessment for sample size determination has been performed. 
SITES:  Up to 20 sites in the United States 
SPONSOR: 
CinDome Pharma, Inc. 
5375 Medpace Way 
Cincinnati, OH 45227 
United States 
 
 

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TABLE OF CONTENTS 
Signature Page ................................................................................................................................ 2 
Investigator Agreement ................................................................................................................... 3 
Synopsis .......................................................................................................................................... 4 
Table of Contents .......................................................................................................................... 11 
List of Tables ................................................................................................................................ 15 
List of Figures ............................................................................................................................... 16 
List of Abbreviations and Definition of Terms............................................................................. 17 
1 Introduction and Background Information ............................................................................. 19 
1.1 
Indication and Treatment Options ................................................................................. 19 
1.2 
CIN-102 ......................................................................................................................... 20 
1.3 
Study Rationale ............................................................................................................. 21 
1.4 
Risk/Benefit ................................................................................................................... 21 
2 Study Objectives ..................................................................................................................... 23 
2.1 
Objectives ...................................................................................................................... 23 
2.2 
Exploratory Objectives .................................................................................................. 23 
3 Study Description.................................................................................................................... 24 
3.1 
Summary of Study Design ............................................................................................ 24 
3.2 
Study Indication ............................................................................................................ 26 
3.3 
Dose Escalation and Review Committee ...................................................................... 26 
3.3.1 Criteria for Temporary Suspension of Dosing .................................................. 26 
3.3.2 Criteria to Cease Dose Escalation ..................................................................... 27 
4 Selection and Withdrawal of subjects ..................................................................................... 28 
4.1 
Inclusion Criteria ........................................................................................................... 28 
4.2 
Exclusion Criteria .......................................................................................................... 29 
4.3 
Randomization Criteria ................................................................................................. 31 
4.4 
Withdrawal Criteria ....................................................................................................... 32 
5 Study Treatments .................................................................................................................... 34 
5.1 
Treatment Groups .......................................................................................................... 34 
5.2 
Rationale for Dosing ..................................................................................................... 34 
5.3 
Randomization and Blinding ......................................................................................... 35 

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5.4 
Breaking the Blind ........................................................................................................ 35 
5.5 
Drug Supplies ................................................................................................................ 35 
5.5.1 Formulation and Packaging ............................................................................... 35 
5.5.2 Study Drug Preparation and Dispensing ........................................................... 35 
5.5.3 Study Drug Administration ............................................................................... 35 
5.5.4 Treatment Compliance ...................................................................................... 36 
5.5.5 Storage and Accountability ............................................................................... 37 
5.6 
Prior and Concomitant Medications and/or Procedures ................................................ 37 
5.6.1 Excluded Medications, Foods, and/or Procedures ............................................ 37 
5.6.2 Rescue Medications ........................................................................................... 38 
5.6.3 Allowed Medications and/or Procedures .......................................................... 38 
5.6.4 Documentation of Prior and Concomitant Medication Use .............................. 38 
6 Study Procedures .................................................................................................................... 39 
6.1 
Informed Consent .......................................................................................................... 39 
6.2 
Pharmacogenomic Assessments .................................................................................... 39 
6.3 
Screening Visit (Days -28 to -11) ................................................................................. 39 
6.4 
Baseline Gastric Emptying Breath Test Visit (Days -10 to -3) ..................................... 40 
6.5 
Pre-Randomization Visit (Days -3 to -1) ...................................................................... 40 
6.6 
Treatment Period – Days 1 to 15 ................................................................................... 42 
6.6.1 Day 1 (Randomization) ..................................................................................... 42 
6.6.2 Day 2 ................................................................................................................. 43 
6.6.3 Day 3 (±1 Day) .................................................................................................. 44 
6.6.4 Days 4 to 6 ......................................................................................................... 44 
6.6.5 Day 7 (±1 Day) .................................................................................................. 45 
6.6.6 Days 8 to 9 ......................................................................................................... 45 
6.6.7 Day 10 (±1 Day) ................................................................................................ 45 
6.6.8 Days 11 to 13 ..................................................................................................... 46 
6.6.9 Day 14 (±2 Days) .............................................................................................. 46 
6.6.10 Day 15 ............................................................................................................... 48 
6.6.11 Follow-up Visit (Day 16 [+ 1 Day]) .................................................................. 48 
6.7 
Early Termination Visit and Withdrawal Procedures ................................................... 49 

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7 Efficacy Assessments.............................................................................................................. 50 
7.1 
Primary Efficacy Assessment ........................................................................................ 50 
7.2 
Secondary Efficacy Assessment .................................................................................... 50 
7.3 
Exploratory Efficacy Assessment ................................................................................. 50 
7.4 
Pharmacokinetics .......................................................................................................... 51 
7.5 
Pharmacogenomic Assessments .................................................................................... 52 
7.5.1 Collection, Storage, and Destruction of Pharmacogenomic Samples ............... 52 
8 Safety Assessments ................................................................................................................. 54 
8.1 
Adverse Events .............................................................................................................. 54 
8.1.1 Adverse (Drug) Reaction .................................................................................. 55 
8.1.2 Unexpected Adverse Drug Reaction ................................................................. 55 
8.1.3 Assessment of Adverse Events by the Investigator .......................................... 55 
8.2 
Serious Adverse Events ................................................................................................. 56 
8.3 
Serious Adverse Event Reporting − Procedures for Investigators ................................ 57 
8.4 
Pregnancy Reporting ..................................................................................................... 58 
8.5 
Expedited Reporting ...................................................................................................... 58 
8.6 
Clinical Laboratory Evaluations .................................................................................... 58 
8.7 
Vital Signs ..................................................................................................................... 59 
8.8 
Electrocardiograms ........................................................................................................ 59 
8.9 
Physical Examinations .................................................................................................. 60 
8.10 Height and Weight ........................................................................................................ 60 
9 Statistics .................................................................................................................................. 61 
9.1 
Analysis Populations ..................................................................................................... 61 
9.2 
Statistical Methods ........................................................................................................ 61 
9.2.1 Analysis of Efficacy .......................................................................................... 61 
9.2.1.1 Primary efficacy analysis .................................................................... 61 
9.2.1.2 Secondary efficacy analysis ................................................................ 61 
9.2.1.3 Exploratory efficacy analysis .............................................................. 61 
9.2.1.4 Pharmacokinetic analysis .................................................................... 62 
9.2.1.5 Pharmacokinetic-Pharmacodynamic analysis ..................................... 62 

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9.2.2 Analysis of Safety ............................................................................................. 62 
9.2.3 Interim Analysis ................................................................................................ 62 
9.2.4 Sample Size Determination ............................................................................... 62 
10 Data Management and Record Keeping ................................................................................. 63 
10.1 Data Management ......................................................................................................... 63 
10.1.1 Data Handling ................................................................................................... 63 
10.1.2 Computer Systems ............................................................................................. 63 
10.1.3 Data Entry ......................................................................................................... 63 
10.1.4 Medical Information Coding ............................................................................. 63 
10.1.5 Data Validation ................................................................................................. 63 
10.2 Record Keeping ............................................................................................................. 63 
11 Investigator Requirements and Quality Control ..................................................................... 64 
11.1 Ethical Conduct of the Study ........................................................................................ 64 
11.2 Institutional Review Board ............................................................................................ 64 
11.3 Informed Consent .......................................................................................................... 64 
11.4 Study Monitoring Requirements ................................................................................... 64 
11.5 Disclosure of Data ......................................................................................................... 65 
11.6 Retention of Records ..................................................................................................... 65 
11.7 Publication Policy ......................................................................................................... 65 
11.8 Financial Disclosure ...................................................................................................... 66 
12 Study Administrative Information .......................................................................................... 67 
12.1 Protocol Amendments ................................................................................................... 67 
13 References ............................................................................................................................... 68 
Appendix A:  Schedule of Procedures .......................................................................................... 70 
Appendix B: Clinical Laboratory Analytes .................................................................................. 74 
Appendix C: Electrocardiogram Alert Criteria Guidance ............................................................ 76 

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LIST OF TABLES 
Table 1.     CTCAE Severity Assessment of Adverse Events ....................................................... 55 
Table 2. 
Schedule of Procedures ............................................................................................... 70 
 

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LIST OF FIGURES 
Figure 1. Study Schematic.......................................................................................................... 25 
 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS  
Abbreviation 
Definition 
 
 
 
 
 
 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
AUC 
Area under the plasma concentration-time curve 
AV 
Atrioventricular 
BID 
Twice daily 
BMI 
Body mass index 
BPM 
Beats per Minute 
BT½ 
Gastric Emptying Breath Test t1/2 (BT t1/2) 
Cmax 
Maximum plasma concentration 
CKD-EPI 
Chronic Kidney Disease Epidemiology Collaboration 
CFR 
Code of Federal Regulations 
CNS 
Central nervous system 
 
 
CRA 
Clinical Research Associate 
CTCAE 
Common Terminology Criteria for Adverse Events 
CYP 
Cytochrome P450 
DGE 
Delayed gastric emptying 
DRC 
Data Review Committee  
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
eGFR 
Estimated glomerular filtration rate 
EIU 
Exposure In Utero 
FDA 
Food and Drug Administration 
FSH 
Follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GEBT 
Gastric emptying breath test 
GI 
Gastrointestinal 
 
 
HBsAg 
Hepatitis B surface antigen 
HCV 
Hepatitis C virus 
HIV 
Human immunodeficiency virus 
ICF 
Informed consent form 
ICH 
International Council for Harmonisation 
IRB 
Institutional Review Board 

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Abbreviation 
Definition 
IRT 
Interactive Response Technology 
IV 
Intravenous 
LBBB 
Left Bundle Branch Block 
MAD 
Multiple-ascending dose 
MITT 
Modified Intent-to-Treat 
MSEC 
Millisecond(s) 
 
 
 
PD 
Pharmacodynamic(s) 
PEG 
Percutaneous endoscopic gastrostomy 
PGx 
Pharmacogenomic 
PK 
Pharmacokinetic(s) 
POC 
Point-of-care 
PP 
Per-Protocol  
QTcF 
Heart rate-corrected QT interval using Fridericia’s formula 
SAD 
Single-ascending dose 
SAE 
Serious adverse event 
 
 
SVT 
Supraventricular tachycardia 
T½ 
Terminal phase elimination half-life 
TSH 
Thyroid-stimulating hormone 
ULN 
Upper limit of normal 

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1 
INTRODUCTION AND BACKGROUND INFORMATION  
1.1 
Indication and Treatment Options 
Gastroparesis is defined as impaired gastric emptying in the absence of physical gastric outlet 
obstruction. Symptoms include early satiety, postprandial fullness, nausea, vomiting, and 
abdominal pain.1 The disease is often associated with diabetes or may occur after gastric surgery; 
it may also be idiopathic from unknown etiologies.2 Gastroparesis affects the patient’s nutritional 
state, especially in diabetics, and severe symptoms of gastroparesis can lead to other complications 
such as malnutrition, esophagitis, and Mallory-Weiss tears.3,4 Gastroparesis negatively impacts 
a patient’s quality of life, causing decreased social interaction, poor work functionality, and 
development of anxiety or depression.3 
The first-line treatment for gastroparesis involves nutritional management and support, including 
fluid and electrolyte replacement. Pharmacologic therapy is directed at increasing gastric emptying 
and accelerating intestinal transit time. Currently, metoclopramide, a dopamine D2 receptor 
antagonist, is the only United States Food and Drug Administration (FDA)-approved agent for the 
treatment of gastroparesis. While effective, this agent readily crosses the blood-brain barrier 
resulting in central nervous system (CNS) side effects in up to 40% of patients.5 Common CNS 
effects associated with metoclopramide treatment include restlessness, drowsiness, fatigue, and 
lassitude; however, the major safety concern with metoclopramide treatment is the development 
of tardive dyskinesia. Tardive dyskinesia is a disorder characterized by involuntary movements of 
the face, tongue, or extremities and is often irreversible. Increased risk of developing tardive 
dyskinesia correlates to treatment duration; therefore, it is recommended that therapy with 
metoclopramide not exceed 12 weeks.6  
Domperidone is a peripheral dopamine D2 receptor antagonist that acts as an antiemetic and 
a prokinetic agent through its effects on the chemoreceptor trigger zone in the area postrema and 
the motor function in the stomach and small intestine.7,8 Domperidone has been available 
worldwide outside of the United States since 1978 as a treatment for gastroparesis as well as 
a general antiemetic. It is currently available in 58 countries, including Canada. In those countries 
where domperidone is approved, the current recommended daily dose is up to 30 mg/day (10 mg 
administered orally 3 times a day) for nausea and vomiting. While available in many countries 
worldwide, domperidone is only available to patients in the United States through 
a physician-initiated Investigational New Drug application at doses up to 120 mg/day (30 mg 
administered orally 4 times per day) for the treatment of gastroparesis and any condition causing 
chronic nausea and vomiting.8 Current treatment guidelines recommend the use of domperidone 
for patients unable to use metoclopramide.9  
Unlike metoclopramide, domperidone does not cross the blood-brain barrier and seldom causes 
extrapyramidal side effects. Similar to other dopamine D2 receptor antagonists, domperidone has 
been shown to raise prolactin levels with chronic administration, but prolactin levels return to 
normal upon discontinuation of the drug.7, 10 Use of domperidone has also been associated with 
QT prolongation. Due to reports of cardiac arrest with the use of intravenous (IV) domperidone, 
the IV dose form was removed from the market. Given the low oral bioavailability of domperidone 
(approximately 13% to 17% of the administered dose),8 oral doses in excess of 1000 mg/day would 
correlate with the IV doses administered to patients at the time when the cardiac issues were 
reported.11 When QT prolongation has been reported with oral domperidone, it has primarily been 
in patients over 60 years of age, in patients taking more than 30 mg/day, in patients with cardiac 

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predispositions, or in patients who were also receiving other QT-prolonging drugs or potent 
cytochrome P450 (CYP) 3A4 inhibitors, such as ketoconazole. However, there have been reports 
of cases of QT prolongation among patients taking domperidone with none of these additional risk 
factors.12,13 The potential for QT prolongation is believed to be related to increased plasma 
concentrations of domperidone. It is suggested that the mean effect on QT of 10 msec (the 
definition of QT prolongation) may occur when the domperidone plasma concentration reaches 
approximately 65 ng/mL.14,15 Therefore, limiting the maximum plasma concentration (Cmax) of 
domperidone to approximately 60 ng/mL may significantly lower the risk of QT prolongation. 
1.2 
CIN-102 
CinDome Pharma, Inc. is currently developing CIN-102, a deuterated form of domperidone. 
A new process was developed to synthesize a deuterated version of domperidone 
 
 
 
 
Given that the 
pharmacological properties of CIN-102 are similar to those of domperidone, CIN-102 is intended 
to provide an alternative for the treatment and relief of symptoms associated with acute and 
recurrent gastroparesis that may have less potential for QT prolongation. 
Two clinical studies of CIN-102 in healthy subjects have commenced to date: a single-ascending 
dose (SAD) study (Study CIN-102-111) and a multiple-ascending dose (MAD) study 
(Study CIN-102-112). 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.3 
Study Rationale 
To date, the PK, pharmacodynamics (PD; based on increases in prolactin), and safety of CIN-102 
have been evaluated in a SAD study and a MAD study in healthy subjects. The current study is 
the first study in subjects with gastroparesis. As such, this study is intended to evaluate the effect 
of CIN-102 on gastric emptying in subjects with idiopathic or diabetic gastroparesis over a range 
of doses. The safety, PK, and effect of CIN-102 on symptoms of gastroparesis in these subjects 
will also be assessed in this proof of concept study. The results of this study will be used to support 
dose selection for future studies.  
1.4 
Risk/Benefit 
Side effects that have been reported by 1% of subjects treated in clinical trials with domperidone 
with a median total daily dose of 80 mg include the following: depression, anxiety, loss of libido, 
headache, somnolence, akathisia, diarrhea, rash, pruritus, gynecomastia, breast tenderness, 
galactorrhea, amenorrhea, breast pain, irregular menstruation, lactation disorders, and asthenia.7 
Less frequently reported adverse events that occurred in <1% of treated subjects include 
hypersensitivity, urticaria, breast discharge, and breast swelling.7 Rare or very rare adverse 
reactions that have been estimated from spontaneous reporting include anaphylactic reactions, 
agitations, nervousness, extrapyramidal disorders, convulsions, sudden cardiac death, ventricular 
arrhythmias, angioedema, urinary retention, abnormal liver tests, and increased blood prolactin.7 
As noted previously, domperidone has been associated with prolongation of the QT interval on 
electrocardiograms (ECGs).16 During postmarketing surveillance, there have been very rare cases 
(<1/10,000 cases) of QT prolongation and QT prolongation-induced Torsades de pointes in 
patients taking oral domperidone.16,17 These reports included patients with confounding risk 
factors, electrolyte abnormalities, and concomitant treatment, which may have been contributing 
factors.17 Epidemiological studies showed that domperidone was associated with an increased risk 
of serious ventricular arrhythmias or sudden cardiac death.16 A higher risk was observed with 
IV administration and following oral administration in patients older than 60 years, patients taking 
total daily oral doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or 
CYP3A4 inhibitors.11,12 However, there have been reports of cases of QT prolongation in patients 
taking domperidone with none of these additional risk factors.12,13 From a review of the literature, 
including an assessment of the thorough QT and case-controlled studies with respect to the 
incidence of QT prolongation and sudden cardiac death, the data appear to indicate that the risk of 
QT prolongation is related to the increased plasma levels of domperidone.11,14,18 Additionally, the 
FDA Expanded Access to Investigational Drugs program website for requesting domperidone 
indicates that the serious risks associated with domperidone are related to domperidone levels in 
the blood, and higher domperidone blood levels are associated with higher risk of these events.19 
Other study-related risks include those associated with blood draws, such as discomfort, bruising, 
infection, bleeding, pain, redness at the puncture site, and/or lightheadedness, as well as temporary 

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discomfort, redness, or rash at the site of ECG electrode placement, and dizziness, headache, 
stomach discomfort, or fainting due to fasting. 
The doses planned for inclusion in this study were chosen based upon the safety, tolerability, and 
PK profile established in the Phase 1 SAD and MAD studies. The mean Cmax of 48.18 ng/mL 
observed in healthy subjects receiving 60 mg BID (the highest proposed dosing regimen for the 
current study) is  below the highest observed mean Cmax from the 120 mg single dose (96.8 ng/mL), 
a dose that was well-tolerated by healthy subjects with no clinically meaningful QT prolongation.  
Given the association of QT prolongation and domperidone, subjects participating in this study 
will be monitored closely for adverse events, including those that have been reported with 
domperidone, and 12-lead ECGs will be collected at each visit to the clinic.  
A goal of this study is to assess the effect of CIN-102 on gastric emptying in subjects with 
idiopathic or diabetic gastroparesis. Given the known antiemetic and prokinetic effects of 
domperidone, it is possible that subjects may experience improvement in their symptoms during 
the course of this study. 

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2 
STUDY OBJECTIVES 
2.1 
Objectives 
The objectives of this study are the following: 
• To evaluate the safety and tolerability of multiple doses of CIN-102 in subjects with idiopathic 
or diabetic gastroparesis 
• To evaluate the effect of multiple doses of CIN-102 on gastric emptying as measured by the 
gastric emptying breath test (GEBT) in subjects with idiopathic or diabetic gastroparesis 
• To characterize the PK of multiple doses of CIN-102 in subjects with idiopathic or diabetic 
gastroparesis  
2.2 
Exploratory Objectives 
The exploratory objectives of this study include the following: 
• To assess the effect of multiple doses of CIN-102 on nausea associated with gastroparesis 
based on the nausea score on the American Neurogastroenterology and Motility Society 
Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) 
• To assess the effect of multiple doses of CIN-102 on ANMS GCSI-DD scores (total and 
subscales) in subjects with idiopathic or diabetic gastroparesis 
• To assess the effect of multiple doses of CIN-102 on a variety of patient reported outcomes 
• To characterize exposure-response relationships of CIN-102 

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3 
STUDY DESCRIPTION 
3.1 
Summary of Study Design 
This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety, efficacy, 
PK, and dose response of oral CIN-102 in adults with idiopathic or diabetic gastroparesis.  
The study will begin by randomizing subjects in Cohort 1 to either CIN-102 
 BID or 
placebo BID in a ratio such that 15 subjects receive CIN-102 and 5 subjects receive placebo. 
Subjects will opt into either a sparse pharmacokinetic sampling subgroup or an intensive PK 
sampling subgroup. The study will be stratified at randomization by idiopathic versus diabetic 
gastroparesis. Efforts will be made to ensure adequate numbers of idiopathic and diabetic 
gastroparetic subjects are included. After approximately 15 subjects in Cohort 1 complete the 
study,  an independent Data Review Committee (DRC) will convene to review the data from 
Cohort 1. The Data Review Committee will review emerging safety, PK, and/or efficacy data 
throughout the study to determine if it is safe and appropriate to continue the study with the 
currently planned dose levels for Cohorts 2 and 3 or if further refinement of the proposed dose 
levels is warranted. Currently planned dose levels for Cohorts 2 and 3 are 
 BID and 
 
BID, respectively, with 15 subjects receiving the study drug and 5 subjects receiving placebo in 
each cohort. However, these planned dose levels may be modified and/or additional cohorts may 
be added based on emerging information from the current study as well as other ongoing studies. 
The highest dose will not exceed 
 BID and no more than 40 additional subjects will be added 
without a protocol amendment. The DRC will also determine how to advance the cohorts (serially 
or simultaneously). Further details regarding the role, responsibilities, and procedures of the DRC 
will be provided in the DRC Charter. 
At the Screening Visit, all subjects will sign informed consent prior to any study procedures being 
performed. Subjects must meet all of the inclusion criteria and none of the exclusion criteria to be 
eligible for study participation.  
Subjects will be evaluated as follows: 
• Days -28 to -11: Screening procedures will be performed. 
 
 
• Day -10 to -3: 
 A GEBT will be 
performed on a single day within this window with breath samples obtained twice prior to 
consumption of a standardized, 13C-enriched meal and then at 45, 90, 120, 150, 180, and 240 
minutes after meal consumption after an 8-hour fast. 
 
 
 
• Day -3 to -1: A Pre-Randomization visit will be completed to perform safety assessments and 
to allow adequate turnaround time of lab results prior to Day 1 (Randomization).  
• Days 1 to 14: Study drug will be administered (CIN-102 or placebo BID for 14 (±2 days) and 
safety assessments will be performed; 
 
and PK blood sampling will be completed at specified timepoints. 
 
 
. 

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3.2 
Study Indication 
CIN-102 is being developed for the treatment and relief of symptoms associated with acute and 
recurrent gastroparesis. 
3.3 
Dose Escalation and Review Committee 
A DRC consisting of at least three members, including a cardiologist, a clinical pharmacologist, 
and an independent clinician experienced in the treatment of patients with idiopathic or diabetic 
gastroparesis will be formed to review emerging PK and safety data in a blinded manner. 
The DRC will convene to review safety and efficacy data through at least Day 14 from 
approximately 15 of the subjects in each cohort. PK data from approximately 8 subjects receiving 
CIN-102 in each cohort will be considered adequate for DRC review (these PK data may be a 
combination of the sparse PK scheme and the intense PK from a subset of subjects). In the event 
a subject discontinues the study at least 24 hours after steady-state is believed to have been 
achieved (based on available data from the SAD and MAD studies) for a reason unrelated to safety, 
the existing data from that individual may be sufficient for decision making by the DRC. 
Dose escalation will only take place after the DRC has determined that is appropriate (eg, adequate 
safety and tolerability have been demonstrated and PK behavior is well enough characterized to 
support proceeding to a higher dose level and/or study of a lower dose level or frequency is 
meaningful based on emerging safety data). 
Upon each DRC review, the following may occur: 
• proceed to the next protocol-specified dose level or  
• proceed to alternate dosing regimen(s) not to exceed the next protocol-specified dose level 
Further detail on DRC conduct will be described in the DRC Charter.   
3.3.1 
Criteria for Temporary Suspension of Dosing 
Dosing within a cohort or between cohorts will be temporarily suspended until a full cumulative 
data review is complete if any of the following occur: 
• Any study drug-related SAE grade 3 or higher based on Common Terminology Criteria for 
Adverse Events (CTCAE) Version 5.0 
• Any single subject whose ECG (average triplicate ECGs as interpreted by central read) 
demonstrates a heart-rate corrected QTcF interval (QTcF) >500 msec or in whom there is an 
increase in QTcF >60 msec from baseline (confirmed by repeat ECG) 
• Any new ECG abnormality deemed clinically significant by the investigator 
• Any study drug-related cardiac adverse event. In the event that a subject experiences a 
vasovagal or near-syncopal episode, dosing within a cohort or subsequent cohort may proceed 
as planned unless the episode is associated with ECG abnormality or the event is deemed to be 
severe in intensity (severity) by the Investigator 
• A study drug-related adverse event from a single System Organ Class deemed to be of 
moderate intensity (severity) in 4 or more subjects 

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• Any of the following laboratory abnormalities that are thought to be study drug-related or in 
which an alternative explanation is not reasonable: 
o ALT or AST >8 × the upper limit of normal (ULN), or 
o ALT or AST >5 × ULN and persist for more than 2 weeks, or 
o ALT or AST >3 × ULN in conjunction with elevated total bilirubin >2 × ULN or 
international normalized ratio >1.5, or 
o ALT or AST >3 × ULN with appearance of fatigue, nausea, vomiting, right upper quadrant 
pain or tenderness, fever, rash, and/or eosinophilia (>5%) 
• Any single subject who develops serious study drug-related electrolyte abnormalities due to 
vomiting and/or inability to maintain adequate oral hydration that impacts cardiac stability 
• Other conditions as deemed medically appropriate based on the Investigator’s judgement 
The Sponsor and/or DRC may also suspend dosing for any other reason based on emerging data. 
Should dosing be temporarily suspended, the DRC can review and discuss all available safety and 
PK data from all subjects participating in the study up until the time of the event. The DRC will 
decide whether knowledge of the treatment assignment of any subject(s) is(are) necessary to make 
an appropriate decision about continuation of the study. If so, a request to unblind will be made 
and relevant data will be reviewed in an unblinded manner. All unblinding Standard Operating 
Procedures will be followed and documented as appropriate. 
Upon completion of the cumulative data review (whether fully blinded or partially unblinded), the 
DRC may elect to terminate the study or to resume study conduct. If study conduct is resumed, the 
DRC may elect to do one of the following: 
• Continue dosing in the current cohort with the same number of subjects originally planned 
• Expand the current cohort with additional subjects to obtain more information at that dose level 
• Escalate to a higher dose level 
• Increase the frequency of dosing at the current dose level (if the protocol-specified number of 
subjects at the current dose level have already completed) 
• De-escalate to a lower dose level 
• Decrease the frequency of dosing at the current dose level 
3.3.2 
Criteria to Cease Dose Escalation 
Dosing within a cohort or between cohorts will cease if either of the following occurs: 
• Any two grade 3 or 1 grade 4 or higher study drug-related SAE based on CTCAE Version 5.0 
• Any 2 subjects with an ECG (average of triplicate ECGs as determined by central read) 
demonstrating QTcF >500 msec or a change in QTcF >60 msec from baseline (confirmed by 
repeat ECG with central read) 
Should one of the above occur, consideration may still be given to continued study of an alternate 
dose level or frequency (either expansion of a previously studied cohort or addition of a lower dose 
level).  

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4 
SELECTION AND WITHDRAWAL OF SUBJECTS  
4.1 
Inclusion Criteria 
Patients who meet all of the following criteria will be eligible to participate in the study: 
1. Male and female patients 18 to 70 years old. 
2. Has a current diagnosis of idiopathic or diabetic gastroparesis as defined by the following: 
o Has gastrointestinal (GI) symptoms felt to be consistent with gastroparesis 
(eg, postprandial nausea/vomiting, postprandial fullness, early satiety,  bloating, and/or 
epigastric/abdominal pain) within the 6 months prior to screening;  
o OR 
o Has documented delayed gastric emptying (DGE) within the past 3 years as determined by 
GEBT or scintigraphy. Patients who have DGE documented through other modalities 
(eg, SmartPill, manometry, etc) or who have had an abnormal GEBT or scintigraphy 
>3 years ago may be considered with Sponsor approval. 
3. Has a body mass index (BMI) between 18 and 40 kg/m2, inclusive. 
4. Has glycosylated hemoglobin level 11% at Screening. 
5. Male patients with female partners of child-bearing potential must agree to use 2 medically 
accepted, highly effective methods of birth control from Day 1 through 60 days following the 
final dose of study drug.  
o Medically accepted, highly effective methods of birth control for male patients with female 
partners of child-bearing potential include the following: latex condom with spermicide, 
diaphragm with intravaginal spermicide, cervical cap with spermicide, indwelling 
intrauterine device (hormonal or nonhormonal), implanted contraceptives, and oral 
contraceptives.  
6. Male patients must agree to abstain from sperm donation from Day 1 through 60 days 
following the final dose of study drug. 
7. Female patients with male partners must be surgically sterile (hysterectomy and/or bilateral 
oophorectomy), postmenopausal for at least 1 year (with confirmed follicle-stimulating 
hormone [FSH] in postmenopausal range at the Screening Visit), or agree to use 2 medically 
accepted, highly effective methods of birth control from Day -14 until 60 days following the 
final dose of study drug.  
o Medically accepted, highly effective methods of birth control for female patients with male 
partners include the following: latex condom with spermicide, diaphragm with intravaginal 
spermicide, cervical cap with spermicide, and nonhormonal indwelling intrauterine device. 
8. Has a negative breath alcohol and urine drug screen (including tetrahydrocannabinol) at the 
Screening Visit and at the time of randomization.  

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9. Is willing to abstain from grapefruit, grapefruit products, star fruit, star fruit products, and 
Seville oranges from 48 hours prior to randomization until end of study. 
 
 
 
 
 
 
11. Is able to understand and willing to comply with all study visits, procedures, restrictions, 
discontinuation of medications, including those to treat gastroparesis (as specified in the 
protocol), and provide written informed consent according to institutional and regulatory 
guidelines. 
4.2 
Exclusion Criteria 
Patients who meet any of the following criteria will be excluded from participation in the study: 
1. Has a history of, or current, clinically significant arrhythmias as judged by the Investigator, 
including ventricular tachycardia, ventricular fibrillation, and Torsades de pointes. Patients 
with minor forms of ectopy (eg, premature atrial contractions) are not necessarily excluded, 
per Investigator discretion. 
2. Has clinically significant bradycardia with a resting heart rate under 50 beats per minute, sinus 
node dysfunction, or heart block. 
3. Has 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. 
4. Has a personal or family history of long QT syndrome, Torsades de pointes, or other complex 
ventricular arrhythmias or family history of sudden death. 
5. Has evidence (based on screening or baseline assessments) or history of clinically significant 
immunologic, hematologic, renal, endocrine, pulmonary, GI, 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.  
Note: Cholecystectomy and appendectomy are allowed. 
6. Has a history of prolactin-releasing pituitary tumor (ie, prolactinoma). 
7. Has elevated serum prolactin.  
Note: Patients who are on medications that are known to increase prolactin (eg, domperidone, 
metoclopramide, phenothiazines, SSRIs, verapamil, etc) with an elevated prolactin at the time 
of screening may be considered for this study. 

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8. Has known or suspected hypogonadism, current clinically significant menstrual abnormalities 
(eg, oligomenorrhea or amenorrhea), gynecomastia, galactorrhea, or other clinical features that 
in the Investigator’s opinion may be consistent with hyperprolactinemia. 
9. Has pyloric injection of botulinum toxin within 6 months of screening and/or during the course 
of the study. 
10. Has bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), or alanine 
aminotransferase (ALT) levels greater than 2 × the upper limit of normal or has a Child-Pugh 
classification grade of B or C. 
11. Has a serum creatinine level greater than 1.5 × the upper limit of normal or has an estimated 
glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 using the Chronic Kidney Disease 
Epidemiology Collaboration (CKD-EPI) equation at screening. 
12. Has a hemoglobin level <10 g/dL at screening.  
13. Has thyroid-stimulating hormone (TSH) levels that are abnormal at screening, as judged by 
the Investigator. 
14. Has inability to perform a breath test. 
15. Has known allergy to eggs or spirulina. 
16. Use of investigational, prescription, or over-the-counter medications as follows: 
o Actively participating in an experimental therapy study; received experimental therapy 
with a small molecule within 30 days of randomization or 5 half-lives (whichever is 
longer); or received experimental therapy with a large molecule within 90 days of 
randomization or 5 half-lives, (whichever is longer). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
17. 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. 
18. Typical consumption of 14 alcoholic drinks weekly. 

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19. Evidence of ongoing illicit drug use. 
20. Positive for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) by RNA, 
or hepatitis B surface antigen (HBsAg) at the Screening Visit. 
21. Donated blood or blood products within 30 days prior to dosing. 
22. Currently undergoing treatment with weight loss medication or prior weight loss surgery 
(eg, gastric bypass surgery). 
23. Pregnant, breastfeeding, or planning to become pregnant during the course of study. 
24. Inability to swallow medication. 
25. Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube 
(eg, percutaneous endoscopic gastrostomy [PEG] tube) for feeding or decompression. 
26. Known or suspected gastric outlet obstruction (eg, peptic stricture) or other GI mechanical 
obstruction as documented by upper GI tract endoscopy or upper GI radiographic series in the 
past 3 years. 
27. Known history or current diagnosis of intestinal malabsorption or pancreatic exocrine disease. 
28. History of gastric surgery such as fundoplication, gastrectomy, vagotomy, pyloroplasty, or 
bariatric procedure.  
Note: Patients who have a gastric pacemaker in place may be considered for the study if the 
pacemaker can be turned off for at least 14 days prior to baseline GEBT and throughout the 
remainder of the study. 
Note: A history of diagnostic endoscopy is not exclusionary. Cholecystectomy and 
appendectomy are allowed. 
29. 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. 
30. Prior lack of response to domperidone or known hypersensitivity or intolerance to 
domperidone or any of the excipients in the CIN-102 formulation. 
31. 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. 
4.3 
Randomization Criteria 
In addition to the general criteria listed in Sections 4.1 and 4.2, in order to be randomized into the 
study, subjects must also meet the following criteria at the time of randomization: 
• Continues to satisfy all inclusion/exclusion criteria. 
• Has been off all motility agents and antiemetics for at least 14 days and is willing to remain 
off such medications (except for protocol-specified antiemetic rescue medication) during the 
course of the study. 

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• Demonstrates a confirmed diagnosis of idiopathic or diabetic gastroparesis as defined by the 
following: 
o Current upper GI symptoms (eg, nausea/vomiting, postprandial fullness, early satiety, 
bloating, and/or epigastric/ abdominal pain). 
o Documented DGE within the 10 days prior to first dose of study drug based on GEBT using 
13C-spirulina platensis demonstrating T½ >80 minutes. Subjects with a T1/2 >200 minutes 
may be considered for the study with sponsor approval.20  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• Has continued required results of the initial safety laboratory test performed at Screening. 
4.4 
Withdrawal Criteria 
Participation of a subject in this clinical study may be discontinued for any of the following 
reasons: 
• Subject withdraws consent or requests discontinuation from the study for any reason. 
• Occurrence of any medical condition or circumstance that exposes the subject to substantial 
risk and/or does not allow the subject to adhere to the requirements of the protocol. 
• Any SAE, clinically significant adverse event, severe laboratory abnormality, clinically 
significant change in ECG from baseline (eg, QTcF > 500 msec, change in QTcF >60 msec 
from baseline (confirmed by repeat ECG with central interpretation), etc.), new ECG 
abnormality deemed clinically significant by the investigator, intercurrent illness, or other 
medical condition which indicates to the Investigator that continued participation is not in the 
best interest of the subject. 
• Pregnancy. 
• Requirement of prohibited concomitant medication. 
• Subject failure to comply with protocol requirements or study-related procedures. 
• Termination of the study by the Sponsor or the regulatory authority. 
If a subject withdraws prematurely from the study due to the above criteria or any other reason, 
study staff should make every effort to complete the full panel of assessments scheduled for the 
Early Termination Visit. The reason for subject withdrawal must be documented in the electronic 
case report form (eCRF). 

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Study enrollment will continue until 60 subjects (15 subjects per treatment) have completed the 
treatment period. Withdrawn subjects will not be replaced. 

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5 
STUDY TREATMENTS 
5.1 
Treatment Groups 
This study is planned to include 4 treatment groups with 15 subjects each.  
At randomization, subjects who meet all eligibility criteria (based on inclusion/exclusion and 
randomization criteria) will be randomized to either CIN-102 BID or placebo BID in a 3:1 ratio. 
The study will begin by randomizing subjects in Cohort 1 to either CIN-102 
 BID or 
placebo BID such that 15 subjects receive CIN-102 and 5 subjects receive placebo. An 
independent DRC will review emerging safety, PK, and/or efficacy data throughout the study to 
determine if it is safe and appropriate to continue the study with the currently planned dose levels 
for Cohorts 2 and 3 or if further refinement of the proposed dose levels is warranted. Currently 
planned dose levels for Cohorts 2 and 3 are 
 BID and 
 BID, respectively, with 15 
subjects receiving study drug and 5 subjects receiving placebo in each cohort. However, these 
planned dose levels may be modified and/or additional cohorts may be added based on emerging 
information from the current study as well as other ongoing studies. The highest dose will not 
exceed 
 BID and no more than 40 additional subjects will be added without a protocol 
amendment. The DRC will also determine how to advance the cohorts. Further details regarding 
the role, responsibilities, and procedures of the DRC will be provided in the DRC Charter. 
The duration of the double-blind treatment period will be 14 days (± 2 days) of study drug 
administration.  
5.2 
Rationale for Dosing 
Two clinical studies of CIN-102 in healthy subjects have commenced to date: a SAD study (study 
CIN-102-111) and a MAD study (study CIN-102-112). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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5.3 
Randomization and Blinding 
Subjects who have completed the Screening Visit and meet all of the inclusion, none of the 
exclusion criteria, and all of the additional criteria based on randomization procedures, including 
safety laboratory tests (see Section 6.5), will be randomized into the study. Randomization will 
occur on Day 1. Randomization assignments will be provided by 
 
 (IRT). Following randomization, study drug will be dispensed in a double-blind 
manner on Day 1. The Sponsor and all clinical personnel will be blinded to the treatment group 
for each subject. Subjects will also be blinded to the treatment they receive. 
Subjects will be stratified at randomization based on their etiology for gastroparesis (ie, diabetic 
gastroparesis versus idiopathic gastroparesis). 
Bioanalytical staff involved in analysis of PK samples will be unblinded to treatment either via 
receipt of the randomization code to allow for analysis of samples from subjects receiving CIN-102 
only (and possibly limited analysis of samples from subjects receiving placebo), or by the nature 
of the results of sample analysis. The PK data will be de-identified before being provided to any 
other individuals, including those involved in calculating PK parameters and associated descriptive 
statistics, performing any modelling or simulations, and/or plotting PK data, in order to maintain 
blinding. 
5.4 
Breaking the Blind 
Blinding is not to be broken during the study unless considered necessary by the Investigator for 
emergency situations for reasons of subject safety. Unblinding at the site for any other reason will 
be considered a protocol deviation. The Investigator should contact the Medical Monitor before 
breaking the blind, if time permits. When the blind is broken, the reason must be fully documented. 
The Investigator will be informed of treatment assignment via 
 IRT. 
5.5 
Drug Supplies 
5.5.1 
Formulation and Packaging 
 
 
 
  
  
 
 
 
 
5.5.2 
Study Drug Preparation and Dispensing 
CIN-102 and matching placebo capsules will be provided to the site by the Sponsor or designee. 
5.5.3 
Study Drug Administration 
All subjects will take a dose of blinded study drug (CIN-102 or placebo capsules) orally at 
AM 
 and 
PM 
 
 
 

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 On 
Day 14 [±2 days], all subjects will fast for a minimum of 8 hours before the morning dose of study 
drug and 4 hours following the completion of the GEBT meal. 
 
 Subjects will be provided study drug for self-
administration for doses not administered at the site. 
In the event that a subject misses their scheduled dose and become aware of the missed dose within 
2 hours of their scheduled dosing time, the subject should be instructed to take their assigned dose 
of study drug at the time they realized that the dose was missed. If the subject should become 
aware of the missed dose more than 2 hours after their scheduled dosing time, the subject should 
be instructed to skip this dose of study drug and resume the assigned dose of study drug at the next 
scheduled time. 
In the event that the subject vomits after taking their scheduled dose of study drug, subjects will 
be instructed to note the time of study drug administration and time of vomiting and to resume 
their assigned dose of study drug at the next scheduled time. During the treatment period, subjects 
should attempt to note the time of vomiting in relation to time of study drug administration and 
report this to site staff during scheduled clinic visits.  
5.5.4 
Treatment Compliance 
Study drug will be administered at the site by site staff during subject confinement and at all 
outpatient visits. A hand and mouth check will be performed by site staff to ensure study drug 
compliance. Dosing compliance will be recorded by the Investigator or designee at the site. The 
date and time of study drug administration will be recorded. 
For all protocol-specified doses when the subject is not at the site, subjects will self-administer 
study drug and will record the date and time of study drug administration. Compliance to study 
drug will also be assessed by clinical site personnel via tablet counts of study drug and by 
questioning the subject, if necessary, upon return to the site on Days 3 [±1 day], 7 [±1 day], 10 [±1 
day], and 14 [±2 days]. A subject who is not compliant (compliance being defined as having taken 
75% of study drug) will be counseled at each visit on the importance of taking study drug as 
instructed. 
If a subject withdraws from the study or does not comply with the study protocol procedures, the 
subject can cease participation in the study but will still be considered evaluable for safety 
purposes. If a subject withdraws from the study or does not comply with the protocol after 
receiving study drug but before Day 14 procedures have been performed, they will be requested 
to undergo the Early Termination procedures. 

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5.5.5 
Storage and Accountability 
Records will be maintained indicating the receipt and dispensation of all study drug supplies. At 
the conclusion of the study, any unused study drug will be returned to the Sponsor or designee for 
final drug accountability and destruction. A certificate of destruction will be provided. If no study 
drug remains, this will be indicated in the Drug Accountability Log. 
 
 
 
5.6 
Prior and Concomitant Medications and/or Procedures 
5.6.1 
Excluded Medications, Foods, and/or Procedures 
Use of the following investigational, prescription, or over-the-counter medications is not permitted 
during the study: 
 
 
 
 
. 
• Experimental therapy with a small molecule within 30 days prior to randomization or 
5 half-lives (whichever is longer); or experimental therapy with a large molecule within 
90 days prior to randomization or 5 half-lives (whichever is longer). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 should be turned off within 14 days prior to baseline GEBT and kept off until end 
of study. 
• Pyloric injection of botulinum toxin within 6 months of screening and during the course of the 
study. 
• Weight loss medication or prior weight loss surgery (eg, gastric bypass surgery). 
• Parenteral feeding or presence of a nasogastric or other enteral tube (eg, PEG tube) for feeding 
or decompression. 

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5.6.2 
Rescue Medications 
  
 
Subjects who require further treatment with prohibited medications may be 
discontinued from study treatment (at discretion of the Investigators and in consult with the 
Sponsor’s Medical Monitor) and undergo follow-up study procedures. 
5.6.3 
Allowed Medications and/or Procedures 
Other medications that are not explicitly and previously excluded are permitted (eg, rescue 
medications in accordance with Section 5.6.2) after approval from the Investigator. 
5.6.4 
Documentation of Prior and Concomitant Medication Use 
Any medications administered 28 days prior to the first dose of study drug and/or during the study 
period must be recorded. 

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6 
STUDY PROCEDURES 
6.1 
Informed Consent 
Written informed consent for the study will be obtained from all subjects before any study 
procedures are performed. See Section 11.3 for details on informed consent. 
6.2 
Pharmacogenomic Assessments 
A single, optional PGx blood sample may be collected at any time during the subject’s participation 
in the study. In order to have a PGx sample collected, subjects must provide written informed 
consent to participate, which is included in the main informed consent form (ICF). The subject 
may withdraw consent to participate in the PGx assessment at any time during the study without 
withdrawing consent to participate in the study. See Section 7.5 for additional details on the PGx 
assessments. 
6.3 
Screening Visit (Days -28 to -11) 
Screening procedures, including vital sign assessments, may be repeated no more than 2 times for 
eligibility purposes. Subjects who are screened but failed to meet inclusion/exclusion criteria 
(despite potentially having undergone repeated screening assessments, if relevant) may be 
considered for rescreening with prior written sponsor approval. 
For all subjects, the Screening Visit will occur up to 28 days prior to randomization (between 
Days -28 and -11). The following procedures will be performed at the Screening Visit: 
• Obtain informed consent. 
• Assess eligibility based on inclusion/exclusion criteria.  
• Record demographics and medical/surgical history.  
• Record prior medications.  
• Perform complete physical examination (general appearance, skin, head, eyes, ears, mouth, 
oropharynx, neck, heart, lungs, abdomen, extremities, and neuromuscular system).  
• Measure height and weight and calculate BMI. 
• Perform breath alcohol test. 
• Collect urine samples for the following: 
o Urinalysis.  
o Urine drug screen.  
• Obtain vital signs (including heart rate, blood pressure, respiration rate, and temperature) while 
subject is sitting after a minimum 5-minute rest. 
• Perform 12-lead ECG (in triplicate approximately 1 minute apart after the subject has been 
resting in the supine position for at least 10 minutes).  
Note: Screening 12-lead ECGs will be printed and will be interpreted as soon as possible by 
the Investigator or Subinvestigator.  

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• Collect blood samples for the following: 
o Chemistry, hematology, coagulation, glycosylated hemoglobin and prolactin.  
o FSH (only for females who have been postmenopausal for at least 1 year and are not 
surgically sterile). 
o TSH. 
o Serum pregnancy test (only for females who are not surgically sterile or postmenopausal 
for at least 1 year [with confirmed FSH in postmenopausal range]). 
o HIV, HBsAg, and HCV screen.  
 
 
 
 
6.4 
Baseline Gastric Emptying Breath Test Visit (Days -10 to -3) 
Baseline GEBT will be performed between Days -10 and -3 after a minimum 14-day washout from 
motility agents. 
The following procedures will be performed at the Baseline GEBT Visit (Days -10 to -3): 
• Assess fasting blood glucose before gastric emptying assessments to ensure a blood glucose of 
275 mg/dL. 
 
 
• Obtain breath samples for GEBT twice prior to consumption of a standardized, 13C-enriched 
meal per the study manual and then at 45, 90, 120, 150, 180, and 240 minutes after meal 
consumption after an 8-hour fast. 
• Record prior medications. 
• Obtain vital signs (including heart rate, blood pressure, respiration rate, and temperature) while 
subject is sitting after a minimum 5-minute rest. 
 
  
6.5 
Pre-Randomization Visit (Days -3 to -1) 
Pre-randomization procedures will be performed at a separate outpatient visit 1 to 3 days prior to 
randomization to allow adequate turnaround time for test results. Preferably, the results of the 
baseline GEBT confirming eligibility would be available prior to the pre-randomization visit 
procedures; however, there may be instances where the pre-randomization visits occurs on the 
same day as the GEBT or prior to the results of the baseline GEBT being available. The safety 
laboratory tests (ie, selected chemistry, hematology, coagulation, and urinalysis as specified 
below) from this visit will be processed at local laboratories for verifying subject eligibility.  Blood 

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and urine samples for clinical safety laboratory and pregnancy tests will also be sent to the central 
laboratory for analysis. Eligibility may be based on Screening prolactin test results. 
The following procedures will be performed at the pre-randomization visit: 
• Assess continued eligibility based on inclusion/exclusion and randomization criteria.  
• Record medical/surgical history.  
• Record prior medications.  
• Collect urine samples for the following: 
o Urinalysis 
o Urine drug screen 
o Collect POC pregnancy test results (only for females who are not surgically sterile or 
postmenopausal for at least 1 year [with confirmed FSH in postmenopausal range at the 
Screening Visit]). 
• Collect blood samples for the following to be reviewed to confirm randomization eligibility: 
o Chemistry including: ALT, AST, alkaline phosphatase, blood urea nitrogen, creatinine, 
lipase, sodium, amylase, bicarbonate, creatinine kinase, eGFR, glucose, potassium, total 
bilirubin 
Note: gamma glutamyl transferase, inorganic phosphorous, total protein, albumin, calcium, 
lactate dehydrogenase, and uric acid levels from Screening will be used to assess 
randomization eligibility and are not required to be repeated at this visit. 
o Prolactin 
Note: Prolactin results from this visit are not required prior to randomization. 
o Hematology including: hematocrit, platelets, white blood cell count and differential, 
hemoglobin, and red blood cell count. 
Note: the glycosylated hemoglobin level from Screening will be used to assess 
randomization eligibility is not required to be repeated at this visit. 
Note: TSH, FSH, HIV/HBsAg/HCV screen will not be repeated. 
 
 
 
 
 

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6.6 
Treatment Period – Days 1 to 15 
For outpatient visits, subjects will report to the clinic before taking their morning dose of study 
drug. 
6.6.1 
Day 1 (Randomization) 
Eligible subjects will be randomized to receive CIN-102 or placebo. Randomization will occur on 
the morning of Day 1. 
The following procedures will be performed on Day 1:  
• Assess continued eligibility based on inclusion/exclusion and randomization criteria.  
• Record any new medical/surgical history prior to randomization.  
• Record concomitant medications (prior to each dose) and adverse events.  
• Perform limited physical examination (minimum of general appearance, skin, heart, lungs, and 
abdomen).  
• Measure weight and calculate BMI using height from the Screening Visit. 
• Perform breath alcohol test. 
• Collect urine sample for: 
o POC urine drug screen.  
• Obtain vital signs (including heart rate, blood pressure, respiration rate, and temperature) while 
subject is sitting after a minimum 5-minute rest. 
• Perform 12-lead ECG 
 
 
  
Note: 12-lead ECGs should be performed in triplicate approximately 1 minute apart after the 
subject has been resting in the supine position for at least 10 minutes. ECGs performed after 
the morning dose should be completed ±15 minutes from the specified timepoints 
 
 
Note: if collection of specific individual PK samples 
 
 are not required based on written 
Sponsor approval, the final ECGs for this visit must be collected when the final PK sample is 
obtained. 
Note: 12-lead ECGs will be printed and will be interpreted as soon as possible by the 
Investigator. A digital recording of each ECG will be submitted to a central reviewer. 
• If the subject continues to meet all eligibility criteria, the subject will be randomized and 
treatment assigned via IRT. 
• Dispense study drug to subject.Administer study drug (all subjects will take a dose of blinded 
study drug [CIN-102 or placebo capsules] orally at 
AM 
 and 
PM 
 
 
Fasting requirements for Day 1 are as follows: 

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• Collect blood samples for the following: 
o Prolactin. Sample collected predose. NOTE: The Day 1 prolactin sample is not required to 
be repeated if a prolactin was obtained for the pre-randomization visit in the last 72 hours. 
o PK analysis: 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
6.6.2 
Day 2 
The following procedures will be performed by the subject on Day 2: 
• Record concomitant medications and adverse events. 
 
 

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• Self-administer study drug (all subjects will take a dose of blinded study drug [CIN-102 or 
placebo capsules] orally at 
AM 
 and 
PM [
 
 
 
 
6.6.3 
Day 3 (±1 Day) 
The following procedures will be performed as an outpatient visit on Day 3 (±1 day): 
• Record concomitant medications and adverse events.  
• Collect urine samples for urinalysis. 
• Obtain vital signs (including heart rate, blood pressure, respiration rate, and temperature) while 
subject is sitting after a minimum 5-minute rest. 
• Perform 12-lead ECG (in triplicate approximately 1 minute apart after the subject has been 
resting in the supine position for at least 10 minutes).  
Note: 12-lead ECGs will be printed and will be interpreted as soon as possible by the 
Investigator. A digital recording of each ECG will be submitted to a central reviewer. 
• Collect blood samples for the following: 
o Chemistry, hematology, coagulation, and prolactin. Sample collected predose. 
o PK analysis 
 
• Administer study drug (all subjects will take a dose of blinded study drug [CIN-102 or placebo 
capsules] orally at 
AM 
 and 
PM 
 
 
 The 
evening dose will be self-administered by the subject. 
• Perform study drug accountability. 
 
 
6.6.4 
Days 4 to 6 
The following procedures will be performed by the subject on Days 4 to 6: 
• Record concomitant medications and adverse events. 
 
 
• Self-administer study drug (all subjects will take a dose of blinded study drug [CIN-102 or 
placebo capsules] orally at 
AM 
 and 
PM 
 
 
 
 

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6.6.5 
Day 7 (±1 Day) 
The following procedures will be performed as an outpatient visit on Day 7 (±1 days): 
• Record concomitant medications and adverse events.  
• Collect urine for urinalysis. 
• Obtain vital signs (including heart rate, blood pressure, respiration rate, and temperature) while 
subject is sitting after a minimum 5-minute rest. 
• Perform 12-lead ECG (in triplicate approximately 1 minute apart after the subject has been 
resting in the supine position for at least 10 minutes).  
Note: 12-lead ECGs will be printed and will be interpreted as soon as possible by the 
Investigator. A digital recording of each ECG will be submitted to a central reviewer. 
• Collect blood samples for the following: 
o Chemistry, hematology, coagulation, and prolactin. Sample collected predose. 
o PK analysis 
 
• Administer study drug (all subjects will take a dose of blinded study drug [CIN-102 or placebo 
capsules] orally at 
AM 
 and self-administer orally at 
PM 
 
 
 
The evening dose will be self-administered by the subject. 
• Perform study drug accountability. 
 
 
6.6.6 
Days 8 to 9 
The following procedures will be performed by the subject on Days 8 and 9: 
• Record concomitant medications and adverse events. 
 
 
• Self-administer study drug (all subjects will take a dose of blinded study drug [CIN-102 or 
placebo capsules] orally at 
AM 
 and 
PM 
 
 
 
 
6.6.7 
Day 10 (±1 Day) 
The following procedures will be performed as an outpatient visit on Day 10 (±1 day): 
• Record concomitant medications and adverse events.  
• Collect urine for urinalysis. 
• Obtain vital signs (including heart rate, blood pressure, respiration rate, and temperature) while 
subject is sitting after a minimum 5-minute rest. 

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• Perform 12-lead ECG 
 
 
  
Note: 12-lead ECGs should be performed in triplicate approximately 1 minute apart after the 
subject has been resting in the supine position for at least 10 minutes. ECGs performed after 
the morning dose should be completed ±15 minutes from the specified timepoints 
 
 
 
 
  
Note: 12-lead ECGs will be printed and will be interpreted as soon as possible by the 
Investigator. A digital recording of each ECG will be submitted to a central reviewer. 
• Fasting blood glucose will be assessed before study drug administration and gastric emptying 
assessments to ensure a blood glucose of 275 mg/dL. 
 
 
 
 
 
• Collect blood samples for the following: 
o Chemistry, hematology, coagulation, and prolactin. Sample collected predose. 
o Serum pregnancy test (only for females who are not surgically sterile or postmenopausal 
for at least 1 year [with confirmed FSH in postmenopausal range at the Screening Visit]). 
o 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
• Obtain breath samples for GEBT (twice prior to consumption of a standardized, 13C-enriched 
meal and then at 45, 90, 120, 150, 180, and 240 minutes after meal consumption). 
• Administer study drug (all subjects will take a dose of blinded study drug [CIN-102 or placebo 
capsules] orally at 
AM 
 
 

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 Study drug will be administered and the subject will consume 
the GEBT meal beginning 30 minutes postdose. The subject will fast for 4 hours after the 
completion of the GEBT meal. 
• Perform study drug accountability and collect unused study drug. 
6.6.10 
Day 15 
The following procedures will be performed as an outpatient visit on Day 15 for all subjects 
participating in the intensive PK subgroup. Subjects participating in the sparse PK subgroup will 
have the option to complete either the Day 15 Visit or the Day 16 (+1 day) Visit (ie, if Day 15 is 
completed, Day 16 (+1 day) is not required): 
• Record concomitant medications and adverse events.  
• Obtain vital signs (including heart rate, blood pressure, respiration rate, and temperature) while 
subject is sitting after a minimum 5-minute rest. 
• Collect blood sample for PK analysis. 
• Perform 12-lead ECG (in triplicate approximately 1 minute apart after the subject has been 
resting in the supine position for at least 10 minutes).  
Note: 12-lead ECGs will be printed and will be interpreted as soon as possible by the 
Investigator. A digital recording of each ECG will be submitted to a central reviewer. 
• For subjects participating in the sparse PK subgroup: collect daily diary materials from subject 
if applicable. This visit will complete the subject’s study participation. 
6.6.11 
Follow-up Visit (Day 16 [+ 1 Day]) 
The following procedures will be performed as an outpatient visit on Day 16 (+1 day) for all 
subjects participating in the intensive PK subgroup and complete the subject’s study participation. 
Subjects participating in the sparse PK subgroup will have the option to complete either the Day 
15 Visit or the Day 16 (+1 day) Visit (ie, if Day 15 is completed, Day 16 (+1 day) is not required): 
• Record prior and concomitant medications and adverse events.  
• Obtain vital signs (including heart rate, blood pressure, respiration rate, and temperature) while 
subject is sitting after a minimum 5-minute rest. 
• Collect blood samples for PK analysis. 
• For subjects participating in the sparse PK subgroup perform 12-lead ECG (in triplicate 
approximately 1 minute apart after the subject has been resting in the supine position for at 
least 10 minutes).  
Note: 12-lead ECGs will be printed and will be interpreted as soon as possible by the 
Investigator. A digital recording of each ECG will be submitted to a central reviewer. 
• Collect daily diary materials from subject if applicable. 

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6.7 
Early Termination Visit and Withdrawal Procedures 
For subjects who are withdrawn from the study prior to completion, the following procedures will 
be performed at the Early Termination Visit: 
• Obtain breath samples for GEBT (twice prior to consumption of a standardized, 13C-enriched 
meal and then at 45, 90, 120, 150, 180, and 240 minutes after meal consumption). 
• Record prior and concomitant medications and adverse events.  
• Collect urine samples for the following: 
o Urinalysis 
o Urine drug screen  
• Perform complete physical examination (general appearance, skin, head, eyes, ears, mouth, 
oropharynx, neck, heart, lungs, abdomen, extremities, and neuromuscular system). 
• Obtain vital signs (including heart rate, blood pressure, respiration rate, and temperature) while 
subject is sitting after a minimum 5-minute rest. 
• Perform 12-lead ECG (in triplicate approximately 1 minute apart after the subject has been 
resting in the supine position for at least 10 minutes).  
Note: 12-lead ECGs will be printed and will be interpreted as soon as possible by the 
Investigator. A digital recording of each ECG will be submitted to a central reviewer. 
o Note: if the subject agrees to perform the GEBT as part of the early-termination visit, the 
ECG collection procedures specified for the Day 14 (±2 days) Visit will be followed. 
• Perform study drug accountability and collect unused study drug. 
• Collect blood samples for the following: 
o Chemistry, hematology, coagulation, and prolactin.  
o Serum pregnancy test (only for females who are not surgically sterile or postmenopausal 
for at least 1 year [with confirmed FSH in postmenopausal range]). 
o PK analysis. 
o Note: if the subject agrees to perform the GEBT as part of the early-termination visit, the 
PK sample procedures specified for the Day 14 (±2 days) Visit will be followed. 
 
 
 
 
 
 
 
 
 
 
 

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7 
EFFICACY ASSESSMENTS 
7.1 
Primary Efficacy Assessment 
The primary efficacy variable is the change from baseline (gathered on Days -10 to -3) in gastric 
emptying as measured by GEBT at Day 14 (±2 days).  
The GEBT is a nonradioactive stable isotope breath test, in which the ratio of exhaled 13CO2/12CO2 
is used to determine the rate of gastric emptying after consumption of a standardized, 13C-enriched 
meal. Subjects will consume a standardized, 13C-enriched meal after an 8-hour fast at baseline 
(Days -10 to -3) and after an 8-hour fast starting 30 minutes after study drug administration on 
Day 14 (±2 days). Breath samples will be obtained twice prior to consumption of a standardized, 
13C-enriched meal and then at 45, 90, 120, 150, 180, and 240 minutes after meal consumption on 
Days -10 to -3 and Day 14 (±2 days) and 30 minutes after study drug administration on Day 14 
(±2 days). 
7.2 
Secondary Efficacy Assessment 
The secondary efficacy variables are the following: 
• The change from baseline in gastric emptying as measured by GEBT T1/2 (BT T1/2)  at Day 14 
(±2 days) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.3 
Exploratory Efficacy Assessment 
 
 
 
 
 
 
 
 
 
 
 

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7.4 
Pharmacokinetics 
For all subjects, blood samples for PK analysis will be collected at the following visits and 
timepoints: 
 
  
 
 
 
 
  
 
 
Subjects may consent to participate in a more intensive PK subgroup. In this subgroup, PK samples 
will also be collected as follows: 
 
  
 
  
 
 
 
 
Note: in some situations, collection of specific, individual PK samples 
 
may not be required in this subset of subjects with prior 
written sponsor approval. 
 
  
The following PK parameters will be calculated for deuterated domperidone (and any measured 
metabolites) using plasma concentrations measured following CIN-102 doses on Day 1 if the data 
permit: 
• Cmax 
• Time to maximum plasma concentration 

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• AUC 0-12 hours 
The following PK parameters will be calculated for deuterated domperidone (and any measured 
metabolites) using plasma concentrations measured following the final dose of CIN-102, if the 
data permit: 
• Cmax 
• Time to maximum plasma concentration 
• AUC over a dosing interval 
• AUC from time 0 to the time of the last quantifiable plasma concentration 
• AUC from time 0 to infinity 
• Percent of AUC extrapolated 
• T½ 
• Apparent plasma clearance 
• Apparent volume of distribution 
Trough concentrations collected throughout the study will be used to confirm compliance and 
attainment of steady-state. 
7.5 
Pharmacogenomic Assessments 
A single, optional PGx blood sample may be collected at any time during the subject’s participation 
in the study. The PGx samples may be used for genetic research to explore the underlying causes 
of variability and/or differences in response in PK, PD, and/or safety data following administration 
of CIN-102. Subjects will be given the option to participate in the PGx assessment during the 
consenting process for the study. In order to have a PGx sample collected, subjects must provide 
written informed consent to participate, which is included in the main ICF. The subject may 
withdraw consent to participate in the PGx assessment at any time during the study without 
withdrawing consent to participate in the study. See Section 7.5.1 for details regarding sample and 
data destruction following withdrawal of consent. The deoxyribonucleic acid sample will not be 
immortalized, sold to anyone, or submitted to a public genetic database. The results obtained from 
analysis of the PGx samples will be accessible to the Sponsor, the party(ies) performing sample 
and/or data analyses, and the party involved in maintenance of the Sponsor’s database. The results 
may be disclosed to the Investigator but are not intended to be provided to the subject. The PGx 
results may be reported and/or published without any of the subject’s personal identification 
information. 
7.5.1 
Collection, Storage, and Destruction of Pharmacogenomic Samples  
For subjects who provide written informed consent to participate in the optional PGx assessment, 
a blood sample will be collected at any time during the subject’s participation in the study. The 
date and time of sample collection will be documented in the subject’s source documents. Each 
sample must be labeled with a unique identifier. Good Laboratory Practice requires a chain of 
custody that is traceable to the sample donor. To ensure subject confidentiality, sample tubes will 
be identified by subject identification number only. 

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Samples will be retained until exhausted or until the Sponsor requests destruction. If the subject 
withdraws consent, the blood samples will be promptly managed regarding proper disposition. 
However, the data will not be discarded if genetic analysis has been completed before the subject 
withdraws consent. 

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8 
SAFETY ASSESSMENTS 
8.1 
Adverse Events 
An adverse event is defined as any untoward medical occurrence in a clinical investigation subject 
administered a pharmaceutical product, which does not necessarily have a causal relationship with 
this treatment. An adverse event can therefore be any unfavorable and/or unintended sign 
(including an abnormal laboratory finding), symptom, or disease temporally associated with the 
use of an investigational medicinal product whether or not related to the investigational medicinal 
product. All adverse events, including observed or volunteered problems, complaints, or 
symptoms, are to be recorded on the appropriate eCRF. 
Adverse events, which include clinical laboratory test variables, will be monitored and 
documented from the time of first dose of study drug until participation is complete. Subjects 
should be instructed to report any adverse event that they experience to the Investigator and/or 
relevant site staff whether or not they think the event is due to study treatment. Beginning at the 
time of first dose of study drug, Investigators should make an assessment for adverse events at 
each visit and record the event on the appropriate adverse event eCRF. 
Wherever possible, a specific disease or syndrome rather than individual associated signs and 
symptoms should be identified by the Investigator and recorded on the eCRF. However, if an 
observed or reported sign or symptom is not considered a component of a specific disease or 
syndrome by the Investigator, it should be recorded as a separate adverse event on the eCRF. 
Additionally, the condition that led to a medical or surgical procedure (eg, surgery, endoscopy, 
tooth extraction, or transfusion) should be recorded as an adverse event, not the procedure itself.  
Any medical condition already present at the time of first dose of study drug should be recorded 
as medical history and not be reported as an adverse event unless the medical condition or signs 
or symptoms present at baseline changes in severity, frequency, or seriousness at any time during 
the study. In this case, it should be reported as an adverse event. 
Clinically significant abnormal laboratory or other examination (eg, ECG) findings that are 
detected during the study or are present at the time of first dose of study drug and significantly 
worsen during the study should be reported as adverse events, as described below. The Investigator 
will exercise his or her medical and scientific judgment in deciding whether an abnormal 
laboratory finding, or other abnormal assessment is clinically significant. Clinically significant 
abnormal laboratory values occurring during the clinical study will be followed until repeat tests 
return to normal, stabilize, or are no longer clinically significant. Abnormal test results that are 
determined to be an error should not be reported as an adverse event. Laboratory abnormalities or 
other abnormal clinical findings (eg, ECG abnormalities) should be reported as an adverse event 
if any of the following are applicable: 
• If an intervention is required as a result of the abnormality 
• If action with the study drug is required as a result of the abnormality 
• Based on the clinical judgment of the Investigator 

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8.1.1 
Adverse (Drug) Reaction 
All noxious and unintended responses to a medicinal product related to any dose should be 
considered an adverse drug reaction. “Responses” to a medicinal product means that a causal 
relationship between a medicinal product and an adverse event is at least a reasonable possibility, 
ie, the relationship cannot be ruled out. 
8.1.2 
Unexpected Adverse Drug Reaction 
An Unexpected Adverse Drug Reaction is defined as an adverse reaction, the nature or severity of 
which is not consistent with the applicable product information. 
8.1.3 
Assessment of Adverse Events by the Investigator 
The Investigator will assess the severity (intensity) of all adverse events (serious and non-serious) 
and will be graded using the CTCAE Version 5.0 criteria as shown in Table 1. The Investigator 
will also categorize each adverse event as to its potential relationship to study drug using the 
categories of yes or no. 
Table 1.     CTCAE Severity Assessment of Adverse Events 
Grade 
Severity 
Description 
1 
Mild 
Asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated 
2 
Moderate 
Minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental activities of daily living* 
3 
Severe 
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting 
self-care activities of daily living** 
4 
Life Threatening 
Life threatening consequences; urgent intervention indicated 
5 
Death 
Death related to AE 
*Instrumental activities of daily living refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. 
**Self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not 
bedridden. 
Ref: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf  
 
Causality assessment: 
The relationship of an adverse event to the administration of the study drug is to be assessed 
according to the following definitions: 
No (unrelated, not related, unlikely to be related) – The time course between the administration of 
study drug and the occurrence or worsening of the adverse event rules out a causal relationship 
and another cause (concomitant drugs, therapies, complications, etc.) is suspected. 
Yes (possibly, probably, or definitely related) – The time course between the administration of 
study drug and the occurrence or worsening of the adverse event is consistent with a causal 

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relationship and no other cause (concomitant drugs, therapies, complications, etc.) can be 
identified. 
The definition implies a reasonable possibility of a causal relationship between the event and the 
study drug. This means that there are facts (evidence) or arguments to suggest a causal relationship. 
The following factors should also be considered: 
• The temporal sequence from study drug administration- 
o The event should occur after the study drug is given. The length of time from study drug 
exposure to event should be evaluated in the clinical context of the event. 
• Underlying, concomitant, intercurrent diseases- 
o Each report should be evaluated in the context of the natural history and course of the 
disease being treated and any other disease the subject may have. 
• Concomitant drug- 
o The other drugs the subject is taking or the treatment the subject receives should be 
examined to determine whether any of them might be recognized to cause the event in 
question. 
• Known response pattern for this class of study drug- 
o Clinical and/or preclinical data may indicate whether a particular response is likely to be a 
class effect. 
• Exposure to physical and/or mental stresses- 
o The exposure to stress might induce adverse changes in the recipient and provide a logical 
and better explanation for the event. 
• The pharmacology and PK of the study drug- 
o The known pharmacologic properties (absorption, distribution, metabolism, and excretion) 
of the study drug should be considered. 
8.2 
Serious Adverse Events 
An adverse event or adverse reaction is considered serious if, in the view of either the Investigator 
or Sponsor, it results in any of the following outcomes: 
• Death. 
• A life-threatening adverse event. 
Note: An adverse event or adverse reaction is considered “life-threatening” if, in view of either 
the Investigator or Sponsor, its occurrence places the subject at immediate risk of death. It does 
not include an event that, had it occurred in a more severe form, might have caused death. 
• Requires hospitalization or prolongation of existing hospitalizations. 
Note: Any hospital admission with at least 1 overnight stay will be considered an inpatient 
hospitalization. An emergency room or urgent care visit without hospital admission will not 
be recorded as a SAE under this criterion, nor will hospitalization for a procedure scheduled 

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or planned before signing of informed consent, or elective treatment of a pre-existing condition 
that did not worsen from Baseline. However, unexpected complications and/or prolongation 
of hospitalization that occur during elective surgery should be recorded as adverse events and 
assessed for seriousness. Admission to the hospital for social or situational reasons (ie, no place 
to stay, live too far away to come for hospital visits, respite care) will not be considered 
inpatient hospitalizations.  
• A persistent or significant disability/incapacity or substantial disruption of the ability to 
conduct normal life functions. 
• A congenital anomaly/birth defect. 
• An important medical event. 
Note: Important medical events that do not meet any of the above criteria may be considered 
an SAE when, based upon appropriate medical judgment, they may jeopardize the subject and 
may require medical or surgical intervention to prevent 1 of the outcomes listed above. 
Examples of such medical events include allergic bronchospasm requiring intensive treatment 
in an emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalizations, or the development of drug dependency. 
8.3 
Serious Adverse Event Reporting − Procedures for Investigators 
Initial Reports 
All SAEs occurring from the time of first dose of study drug until 30 days following the final dose 
of study drug must be reported to 
 within 24 hours of the knowledge of 
the occurrence. After the 30-day reporting window, any SAE that the Investigator considers related 
to study drug must be reported to 
 or the Sponsor/designee. Of note, 
reporting of SAEs after the follow-up phone call 72 hours after discharge is dependent on 
spontaneous reporting by the subject. The Investigator is not required to have further contact to 
elicit this information after completion of the follow-up phone call but should instruct the subject 
to contact the site to report any such events.  
To report the SAE, complete the SAE form electronically in the electronic data capture (EDC) 
system for the study. When the form is completed, 
 personnel will be notified 
electronically by the EDC system and will retrieve the form. If the event meets serious criteria and 
it is not possible to access the EDC system, send an e-mail to 
 
 at 
 or call the 
 reporting line (phone 
number listed below), and fax/e-mail the completed paper SAE form to 
 (fax number 
listed below) within 24 hours of awareness. When the EDC system becomes available, the SAE 
information must be entered within 24 hours of the system becoming available. 
Safety Contact Information: 
 
 
 
 
 
Follow-Up Reports 
(b)

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The Investigator must continue to follow the subject until the SAE has subsided or until the 
condition becomes chronic in nature, stabilizes (in the case of persistent impairment), or the subject 
dies. 
Within 24 hours of receipt of follow-up information, the Investigator must update the SAE form 
electronically in the EDC system for the study and submit any supporting documentation 
(eg, patient discharge summary or autopsy reports) to 
 via fax or e-mail. 
If it is not possible to access the EDC system, refer to the procedures outlined above for initial 
reporting of SAEs. 
8.4 
Pregnancy Reporting 
If a subject becomes pregnant during the study or within the safety follow-up period defined in the 
protocol, the Investigator is to stop dosing with study drug(s) immediately and the subject should 
be withdrawn from the study. Early termination procedures should be implemented at that time.  
A pregnancy is not considered to be an adverse event or SAE; however, it must be reported to 
 within 24 hours of knowledge of the event. 
 will 
then provide the Investigator/site the Exposure In Utero (EIU) form for completion. The 
Investigator/site must complete the EIU form and fax or e-mail it back to 
  
If the female partner of a male subject becomes pregnant while the subject is receiving study drug 
or within the safety follow-up period defined in the protocol, the Investigator should notify 
 as described above.  
The pregnancy should be followed until the outcome of the pregnancy, whenever possible. Once 
the outcome of the pregnancy is known, the EIU form should be completed and faxed/e-mailed to 
. If the outcome of the pregnancy meets the criteria for immediate 
classification as an SAE (ie, postpartum complication, spontaneous abortion, stillbirth, neonatal 
death, or congenital anomaly), the Investigator should follow the procedures for reporting an SAE. 
8.5 
Expedited Reporting 
The Sponsor will report all relevant information about suspected unexpected serious adverse 
reactions that are fatal or life-threatening as soon as possible to the FDA and in any case no later 
than 7 days after knowledge by the Sponsor/designee of such a case, and the relevant follow-up 
information will subsequently be communicated within an additional 8 days.  
All other suspected unexpected serious adverse reactions will be reported to the FDA as soon as 
possible but within a maximum of 15 days of first knowledge by the Sponsor/designee.  
The Sponsor/designee will also inform all Investigators as required. 
8.6 
Clinical Laboratory Evaluations 
Safety laboratory tests will include chemistry, hematology, coagulation, prolactin, and urinalysis. 
See Appendix B for a complete list of analytes.  
Safety laboratory tests will be evaluated at the times indicated in the Schedule of Procedures table 
in Appendix A.  
Abnormal screening laboratory tests may be repeated no more than 2 times for eligibility purposes.  

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If, in the opinion of the Investigator, any subject has a clinically significant abnormal laboratory 
finding in comparison to the value at the time of randomization or unresolved TEAEs, additional 
follow-up visits will be scheduled. Subjects will be followed approximately once a week (or more 
frequently as deemed appropriate) until the Investigator determines that repeat laboratory findings 
are clinically unremarkable in comparison to baseline, or unresolved adverse events return to 
prestudy levels or clinically acceptable levels. 
If a subject experiences an SAE for which follow-up laboratories and review are required, the 
Investigator will schedule additional postdose visits as necessary. 
If, in the opinion of the Investigator, any subject has a clinically significant adverse event at the 
follow-up call, the Investigator will provide additional follow-up until the adverse event returns to 
clinically acceptable levels. 
The safety laboratory sample collection times may be refined based on emerging data to ensure 
study objectives are met. 
8.7 
Vital Signs 
Vital signs, including heart rate, blood pressure, respiration rate, and temperature, will be measured 
at the times indicated in the Schedule of Procedures table in Appendix A using the following 
standardized procedures: 
• Prior to measuring vital signs, the subject should be sitting for a minimum of 5 minutes with 
his/her back supported, feet flat on the floor, and his/her measurement arm supported so that 
the midpoint of the manometer cuff is at heart level. 
• An appropriately sized cuff should be used with the bladder centered over the brachial artery. 
• The cuff size and arm used for the measurement should be recorded. Whenever possible, the 
same arm should be used for all vital sign assessments throughout the study. 
• Blood pressure should be recorded to the nearest whole number on an automatic device. 
8.8 
Electrocardiograms 
Twelve-lead ECGs will be performed at the times indicated in the Schedule of Procedures table in 
Appendix A.  
Every effort will be made to eliminate any sources of physical (including any movement, eating, 
or drinking) or electrical interference. During these assessments, subjects are not permitted to use 
cell phones, iPods, laptop computers, tablets, or any type of battery-operated or electrical device, 
and all of these devices must be turned off during the assessments. 
All 12-lead ECGs will be performed in triplicate approximately 1 minute apart after the subject 
has been resting in the supine position for at least 10 minutes. The average QTcF will be used for 
eligibility and safety assessments. Twelve-lead ECGs will be printed and will be interpreted as 
soon as possible by an Investigator (or Subinvestigator for Screening Visit only). All ECGs 
collected at the time of randomization and throughout the treatment period must be evaluated for 
the presence of abnormalities by a qualified physician. A digital recording of all ECGs for 
randomized subjects will be submitted to a central reviewer. The central overread ECG data will 
be utilized for all safety assessments and analyses. 

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Standard ECG parameters will be measured, and the following ECG parameters will be recorded: 
• QRS interval 
• Heart rate 
• RR interval 
• QT interval 
• QTc (QTcF) 
Investigators should contact the Sponsor or designee if any clinically meaningful changes from 
baseline are noted on review. Please refer to Appendix C for ECG alert criteria guidance. 
8.9 
Physical Examinations 
Complete physical examinations will be performed at the times indicated in the Schedule of 
Procedures table in Appendix A. A complete physical examination will consist of general 
appearance, skin, head, eyes, ears, mouth, oropharynx, neck, heart, lungs, abdomen, extremities, 
and neuromuscular system. 
Brief limited physical examinations will be performed at the times indicated in the Schedule of 
Procedures table in Appendix A. A limited physical examination will consist of a minimum of 
general appearance, skin, heart, lungs, and abdomen. 
All complete and limited physical examination findings must be recorded. 
8.10 
Height and Weight 
Height and weight will be measured at the times indicated in the Schedule of Procedures table in 
Appendix A and will be used to calculate BMI. Height will be measured with the subject’s shoes 
off. Weight will be measured with the subject’s shoes off and after the subject’s bladder has been 
emptied. 

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9.2.1.4 
Pharmacokinetic analysis 
The CIN-102 plasma concentrations and PK parameters will be listed by individual and 
summarized by treatment for active treatments in tabular format using descriptive statistics. 
CIN-102 plasma concentrations will be plotted against timepoints by regimen (mean and 
individual). 
9.2.1.5 
Pharmacokinetic-Pharmacodynamic analysis 
 If the data permit, an attempt will be made to correlate plasma concentration and/or PK parameters 
with select safety measures, prolactin data, and/or measures of gastric emptying time and 
symptoms of gastroparesis. 
9.2.2 
Analysis of Safety 
Safety data, including physical examinations, ECGs, vital sign assessments, clinical laboratory 
evaluations (including prolactin), and adverse events, will be summarized by treatment group and 
time of collection, when appropriate. Individual and mean time course of absolute prolactin values 
and change from baseline prolactin by treatment may also be generated. 
Descriptive statistics (arithmetic mean, standard deviation, median, minimum, and maximum) will 
be calculated for quantitative safety data, as well as for the difference from baseline, when 
appropriate. Absolute and change from baseline values in QT (using QTcF) will be plotted against 
timepoints by treatment, if applicable. The central overread ECG data will be utilized for all safety 
assessments and analyses. 
Shift tables describing out-of-normal range shifts will be provided for clinical laboratory results. 
9.2.3 
Interim Analysis 
An independent DRC will review emerging safety, PK, and/or efficacy data throughout the study 
to determine if it is safe and appropriate to continue the study with the currently planned dose 
levels for Cohorts 2 and 3 or if further refinement of the proposed dose levels is warranted. The 
DRC will also determine how to advance the cohorts. Further details regarding the role, 
responsibilities, and procedures of the DRC will be provided in the DRC Charter. 
9.2.4 
Sample Size Determination 
A total of 60 subjects (15 subjects per treatment) will be randomized to CIN-102 
 BID, 
CIN-102 
 BID, CIN-102 
 BID, or placebo. The sample size is considered adequate to 
provide the necessary data to evaluate the objectives of the study. No formal statistical assessment 
for sample size determination has been performed.  

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10 
DATA MANAGEMENT AND RECORD KEEPING 
10.1 
Data Management 
10.1.1 
Data Handling 
Data will be recorded at the site on eCRFs and reviewed by the clinical research associate (CRA) 
during monitoring visits. The CRAs will verify data recorded in the EDC system with source 
documents. All corrections or changes made to any study data must be appropriately tracked in an 
audit trail in the EDC system. An eCRF will be considered complete when all missing, incorrect, 
and/or inconsistent data has been accounted for. 
10.1.2 
Computer Systems 
Data will be processed using a validated computer system conforming to regulatory requirements. 
10.1.3 
Data Entry 
Data must be recorded using the EDC system as the study is in progress. All site personnel must 
log into the system using their secure username and password in order to enter, review, or correct 
study data. These procedures must comply with Title 21 of the Code of Federal Regulations 
(21 CFR Part 11) and other appropriate international regulations. All passwords will be strictly 
confidential. 
10.1.4 
Medical Information Coding 
For medical information, the following thesauri will be used: 
• Medical Dictionary for Regulatory Activities (latest) for medical history and adverse events 
• World Health Organization Drug Dictionary for prior and concomitant medications 
10.1.5 
Data Validation 
Validation checks programmed within the EDC system, as well as supplemental validation 
performed via review of the downloaded data, will be applied to the data in order to ensure 
accurate, consistent, and reliable data. Data identified as erroneous, or data that are missing, will 
be referred to the investigative site for resolution through data queries. 
The eCRFs must be reviewed and electronically signed by the Investigator. 
10.2 
Record Keeping 
Records of subjects, source documents, monitoring visit logs, eCRFs, inventory of study product, 
regulatory documents, and other Sponsor correspondence pertaining to the study must be kept in 
the appropriate study files at the site. Source data is defined as all information in original records 
and certified copies of original records of clinical findings, observations, or other activities in a 
clinical study necessary for the evaluation and reconstruction of the clinical study. Source data are 
contained in source documents (original records or certified copies). These records will be retained 
in a secure file for the period as set forth in the Clinical Study Agreement. Prior to transfer or 
destruction of these records, the Sponsor must be notified in writing and be given the opportunity 
to further store such records.  

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11 
INVESTIGATOR REQUIREMENTS AND QUALITY CONTROL  
11.1 
Ethical Conduct of the Study 
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for 
designing, conducting, recording, and reporting studies that involve human subjects. Compliance 
with this standard provides public assurance that the rights, safety, and well-being of study subjects 
are protected, consistent with the principles that have their origin in the Declaration of Helsinki, 
and that the clinical study data are credible. 
11.2 
Institutional Review Board 
The Institutional Review Board (IRB) will review all appropriate study documentation in order to 
safeguard the rights, safety, and well-being of subjects. The study will only be conducted at sites 
where IRB approval has been obtained. The protocol, Investigator’s Brochure, ICF, advertisements 
(if applicable), written information given to the subjects, safety updates, annual progress reports, 
and any revisions to these documents will be provided to the IRB by the Investigator. 
Federal regulations and International Council for Harmonisation (ICH) Guidelines require that 
approval be obtained from an IRB prior to participation of subjects in research studies. Prior to 
study onset, the protocol, any protocol amendments, ICFs, advertisements to be used for subject 
recruitment, and any other written information regarding this study to be provided to a subject or 
subject’s legal guardian must be approved by the IRB. 
No drug will be released to the site for dosing until written IRB authorization has been received 
by the Sponsor. 
11.3 
Informed Consent 
The ICF and any changes to the ICF made during the course of the study must be agreed to by the 
Sponsor or designee and the IRB prior to its use and must be in compliance with all ICH GCP, 
local regulatory requirements, and legal requirements.  
The Investigator must ensure that each study subject is fully informed about the nature and 
objectives of the study and possible risks associated with participation and must ensure that the 
subject has been informed of his/her rights to privacy. The Investigator will obtain written 
informed consent from each subject before any study-specific activity is performed and should 
document in the source documentation that consent was obtained prior to enrollment in the study. 
The original signed copy of the ICF must be maintained by the Investigator and is subject to 
inspection by a representative of the Sponsor, their representatives, auditors, the IRB, and/or 
regulatory agencies. A copy of the signed ICF will be given to the subject. 
11.4 
Study Monitoring Requirements 
It is the responsibility of the Investigator to ensure that the study is conducted in accordance with 
the protocol, Declaration of Helsinki, ICH GCP, and applicable regulatory requirements, and that 
valid data are entered into the eCRFs. 
To achieve this objective, the CRA’s duties are to aid the Investigator and, at the same time, the 
Sponsor in the maintenance of complete, legible, well-organized and easily retrievable data. Before 
the enrollment of any subject in this study, the Sponsor or their designee will review with the 
Investigator and site personnel the following documents: protocol, Investigator’s Brochure, eCRFs 

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and procedures for their completion, informed consent process, and the procedure for reporting 
SAEs. 
The Investigator will permit the Sponsor or their designee to monitor the study as frequently as 
deemed necessary to determine that data recording and protocol adherence are satisfactory. During 
the monitoring visits, information recorded on the eCRFs will be verified against source 
documents and requests for clarification or correction may be made. After the eCRF data is entered 
by the site, the CRA will review the data for safety information, completeness, accuracy, and 
logical consistency. Computer programs that identify data inconsistencies may be used to help 
monitor the clinical study. If necessary, requests for clarification or correction will be sent to the 
Investigators. The Investigator and his/her staff will be expected to cooperate with the monitor and 
provide any missing information, whenever possible. 
All monitoring activities will be reported and archived. In addition, monitoring visits will be 
documented at the investigational site by signature and date on the study-specific monitoring log. 
11.5 
Disclosure of Data 
Data generated by this study must be available for inspection by the FDA, the Sponsor or their 
designee, applicable foreign health authorities, and the IRB as appropriate. Subjects or their legal 
representatives may request their medical information be given to their personal physician or other 
appropriate medical personnel responsible for their welfare. 
Patient medical information obtained during the study is confidential and disclosure to third parties 
other than those noted above is prohibited. 
11.6 
Retention of Records 
To enable evaluations and/or audits from regulatory authorities or the Sponsor, the Investigator 
will keep records, including the identity of all participating subjects (sufficient information to link 
records; eg, eCRFs and hospital records), all original signed ICFs, copies of all eCRFs, SAE forms, 
source documents, and detailed records of treatment disposition. The records should be retained 
by the Investigator according to specifications in the ICH guidelines, local regulations, or as 
specified in the Clinical Study Agreement, whichever is longer. The Investigator must obtain 
written permission from the Sponsor before disposing of any records, even if retention 
requirements have been met. 
If the Investigator relocates, retires, or for any reason withdraws from the study, the Sponsor should 
be prospectively notified. The study records must be transferred to an acceptable designee, such 
as another Investigator, another institution, or to the Sponsor.  
11.7 
Publication Policy 
Following completion of the study, the data may be considered for publication in a scientific 
journal or for reporting at a scientific meeting. Each Investigator is obligated to keep data 
pertaining to the study confidential. The Investigator must consult with the Sponsor before any 
study data are submitted for publication. The Sponsor reserves the right to deny publication rights 
until mutual agreement on the content, format, interpretation of data in the manuscript, and journal 
selected for publication are achieved. 

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11.8 
Financial Disclosure 
Investigators are required to provide financial disclosure information to the Sponsor to permit the 
Sponsor to fulfill its obligations under 21 CFR Part 54. In addition, Investigators must commit to 
promptly updating this information if any relevant changes occur during the study and for a period 
of 1 year after the completion of the study. 

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12 
STUDY ADMINISTRATIVE INFORMATION 
12.1 
Protocol Amendments 
Any amendments to the study protocol will be communicated to the Investigators by 
 or 
the Sponsor. All protocol amendments will undergo the same review and approval process as the 
original protocol. A protocol amendment may be implemented after it has been approved by the 
IRB, unless immediate implementation of the change is necessary for subject safety. In this case, 
the situation must be documented and reported to the IRB within 5 working days. 

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13 
REFERENCES 
1. Bielefeldt K. Gastroparesis: concepts, controversies, and challenges. Scientifica (Cairo). 
2012;2012:424802. 
2. Parkman HP, Jacobs MR, Mishra A, et al. Domperidone treatment for gastroparesis: 
demographic and pharmacogenetic characterization of clinical efficacy and side-effects. 
Dig Dis Sci. 2011;56(1):115-124. 
3. US Department of Health and Human Services, Food and Drug Administration, Center 
for Drug Evaluation and Research (CDER). Gastroparesis: clinical evaluation of drugs 
for treatment. Guidance for industry [draft guidance]. July 2015. 
4. Camilleri M, Bharucha AE, Farrugia G. Epidemiology, mechanisms, and management of 
diabetic gastroparesis. Clin Gastroenterol Hepatol. 2011;9(1):5-12. 
5. Ortiz A, Cooper CJ, Alvarez A, et al. Cardiovascular safety profile and clinical 
experience with high-dose domperidone therapy for nausea and vomiting. Am J Med Sci. 
2015;349(5):421-424. 
6. 
 
 
7. Motilium® (domperidone) [product information]. Macquarie Park, NSW, Australia. 
Janssen-Cilag Pty Ltd. 04 February 2019. 
8. Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and 
clinical applications in gastroenterology. Am J Gastroenterol. 2007;102(9):2036-2045. 
9. Camilleri M, Parkman HP, Shafi MA, et al. Clinical guideline: management of 
gastroparesis. Am J Gastroenterol. 2013;108(1):18-37. 
10. Fitzgerald P, Dinan TG. Prolactin and dopamine: what is the connection? A review 
article. J Psychopharmacol. 2008;22(2 Suppl):12-19. 
11. Buffery PJ, Strother RM. Domperidone safety: a mini-review of the science of QT 
prolongation and clinical implications of recent global regulatory recommendations. 
N Z Med J. 2015;128(1416):66-74. 
12. European Medicines Agency, Pharmacovigilance Risk Assessment Committee (PRAC). 
Assessment report. Domperidone-containing medicinal products. March 2014. 
13. FDA Briefing Document (Domperidone). Pharmacy Compounding Advisory Committee 
Meeting. October 2015. 
14. Biewenga J, Keung C, Solanki B, et al. Absence of QTc prolongation with domperidone: 
a randomized, double‐blind, placebo‐ and positive‐controlled thorough QT/QTc study in 
healthy volunteers. Clin Pharmacol Drug Dev. 2015;4(1):41-48. 
 
      15. US Department of Health and Human Services, Food and Drug Administration, Center 
for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and 
Research (CBER). E14 clinical evaluation of QT/QTc interval prolongation and 
proarrhythmic potential for non-antiarrhythmic drugs. Guidance for Industry. 
October 2005. 
16. Motilium® (domperidone) [datasheet]. Auckland, New Zealand. Janssen-Cilag 
(New Zealand) Ltd. 02 May 2016. 
17. Food and Drug Administration, Center for Drug Evaluation and Research. Pharmacy 
Compounding Advisory Committee (PCAC) Meeting transcript. 28 October 2015. 
 
 

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18. Boyce MJ, Baisley KJ, Warrington SJ. Pharmacokinetic interaction between 
domperidone and ketoconazole leads to QT prolongation in healthy volunteers: a 
randomized, placebo-controlled, double-blind, crossover study. Br J Clin Pharmacol. 
2012;73(3):411-421. 
19. US Food and Drug Administration. How to request domperidone for expanded access 
use. 
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandappro
ved/approvalapplications/investigationalnewdrugindapplication/ucm368736.htm. 
Accessed 09 August 2018. 
20. Bharucha AE, Camilleri, M, Veil, E. Comprehensive assessment of gastric emptying with 
a stable isotope breath test. Neurogastroenterol Motil. 2013;25(1). 

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APPENDIX A:  SCHEDULE OF PROCEDURES 
Table 2. Schedule of Procedures 
Study Day 
Screening  
Baseline 
GEBT [16] 
Pre-
Randomization 
Treatment Period 
Follow
-up 
-28 to -11 
-10 to -3 
-3 to -1 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 11 12 
13 
14 
15 [22] 
16 [22] 
Visit Window (Days) 
 
 
 
 
 
±1 
 
 
 
±1 
 
 
±1 
 
 
 
±2 
 
+1 
Clinic Visit Day 
X 
X 
X 
X 
 
X 
 
 
 
X 
 
 
X 
 
 
 
X 
X 
X 
PK Sampling Details 
Multiple PK sample [1] 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Single PK sample [2] 
 
 
 
 
 
X 
 
 
 
X 
 
 
X 
 
 
 
 
X 
[2,23] 
 
Procedure 
Informed consent [3] 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
I/E criteria [4] 
X 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization criteria 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical/surgical history 
X 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior and concomitant 
medications [5] 
X 
Adverse events [6] 
 
 
 
X 
Complete physical 
examination [7] 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Limited physical 
examination [7] 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight and height [8] 
X 
 
 
X[8] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital signs [9] 
X 
X 
X 
X 
 
X 
 
 
 
X 
 
 
X 
 
 
 
X 
X[23] 
X 
Breath alcohol test 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drug screen 
X 
 
X 
X[11] 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Urinalysis 
X 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
 
 
X 
 
 
HIV/HBsAg/HCV screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FSH [10] 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TSH 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy test [12] 
X 
 
X[12] 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
12-lead ECG [13]  
X 
 
 
X 
[14] 
 
X 
 
 
 
X 
 
 
X 
 
 
 
X 
[14] 
X[23] 
 
GEBT [15]  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
See footnotes at the end of the table on the following page. 

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Table 2. Schedule of Procedures (Continued) 
Study Day 
Screening 
Baseline 
GEBT [16] 
Pre-
Randomization 
Treatment Period 
Follow-
up 
-28 to -11 
-10 to -3 
-3 to -1 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 11 12 13 
14 
15 [22] 
16 [22] 
Visit Window (Days) 
 
 
 
 
 
±1 
 
 
 
±1 
 
 
±1 
 
 
 
±2 
 
+1 
Chemistry, hematology, 
and coagulation 
X 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
 
 
X 
 
 
Glycosylated 
hemaglobin 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prolactin [17] 
X 
 
X 
X[17] 
 
X 
 
 
 
X 
 
 
X 
 
 
 
X 
 
 
Randomize Subject 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dispense study drug 
[18] 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study drug 
administration [19] 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Study drug 
accountability and 
collection of unused 
study drug [20] 
 
 
 
 
 
X 
 
 
 
X 
 
 
X 
 
 
 
X 
 
 
Collection of electronic 
diary materials 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X[23] 
 
PGx sample (optional) 
[21] 
X 
Note: All days will be reported as the next nominal day in sequential order (ie, if the outpatient visit Day 3 [±1 Day] takes place on the sequential Day 4, it will be recorded as 
Day 4. All following days will be recorded likewise).  
1. 
On Day 1, all subjects will be confined to the clinic 
 Blood samples for PK analysis will be 
collected from all subjects 
 
 
 
 
 
 
  
2. 
On Days 3 (±1 day), 7 (±1 day), and 10 (±1 day), all subjects will report to the clinic for an outpatient visit. Blood samples for PK analysis will be taken prior to the 
morning dose of study drug (within 5 minutes). Subjects in the intensive PK subgroup will report to the clinic on the day following their last dose of study drug (Day 15) 
and on Day 16 (+1 day) and a PK sample will be collected at each visit. Subjects in the sparse PK subgroup may report to the clinic on either Day 15 or Day 16 (+1 day) 
and a PK sample will be collected at this visit. 
3. 
Written informed consent for the study will be obtained from all subjects before any study procedures are performed. 

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4. 
Screening procedures, including vital sign assessments, may be repeated no more than 2 times for eligibility purposes.  
5. 
Any medications administered 28 days prior to the first dose of study drug and during the study period must be recorded. Starting on Day 1, concomitant medications will 
be recorded by the subject prior to each dose and recorded by the Investigator at each outpatient visit prior to each dose. 
6. 
Adverse events will be monitored and documented by the subject and by the Investigator at each outpatient visit from the time first dose of study drug until study 
participation is complete. 
7. 
A complete physical examination will consist of general appearance, skin, head, eyes, ears, mouth, oropharynx, neck, heart, lungs, abdomen, extremities, and 
neuromuscular system. A limited physical examination will consist of a minimum of general appearance, skin, heart, lungs, and abdomen. 
8. 
Height will be measured at the Screening Visit only. Body mass index will be calculated at the Screening Visit using height and weight collected at the Screening Visit. At 
the time of randomization (Day 1), BMI will be calculated using weight from the time of randomization (Day 1) and height from the Screening Visit.  
9. 
Vital signs including heart rate, blood pressure, respiration rate, and temperature and will be collected while subject is sitting after a minimum 5-minute rest. 
10. Follicle-stimulating hormone will only be measured for females who have been postmenopausal for at least 1 year and are not surgically sterile. 
11. At the time or randomization (Day 1), a POC drug test will be performed for use in assessing eligibility. A urine sample will also be sent to the central lab for confirmatory 
testing. 
12. A pregnancy test will only be performed in females who are not surgically sterile (or postmenopausal for at least 1 year [with confirmed FSH in postmenopausal range at 
the Screening Visit]). A serum pregnancy test will be performed by the central lab on Days -28 to -11 and Day 14 (±2 days). A POC pregnancy test will initially be 
performed on the Day -3 to -1 visit for use in assessing randomization eligibility. 
13. All 12-lead ECGs will be performed in triplicate approximately 1 minute apart after the subject has been resting in the supine position for at least 10 minutes. Twelve-lead 
ECGs will be printed and will be interpreted as soon as possible by an Investigator (or Subinvestigator for Screening Visit only). A digital recording of all ECGs from 
randomized subjects will be submitted to a central reviewer. ECGs should be completed ±15 minutes from all specified time points. 
14. On Days 1 and 14 (±2 days), ECGs will be performed prior to the morning dose and 
 hours (as applicable) after the morning dose and should be completed 
±15 minutes from the specified timepoints. For subjects participating in the intensive PK, additional ECGs will be performed at 
 (if applicable) after the 
morning dose). Note: if collection of specific individual PK samples (including but not limited to the samples at 
 for the intense PK subgroup) 
are not required based on written Sponsor approval, the final ECGs for these visits must be collected when the final PK sample is obtained. See Appendix C for ECG 
review criteria guidance. 
15. Subjects will have baseline GEBT performed between Days -10 and -3 after a minimum 14-day washout from motility agents and on Day 14 (±2 days) 30 minutes after 
study drug administration. Subjects will fast for a minimum of 8 hours before the breath test. Breath samples will be obtained twice prior to consumption of a standardized, 
13C-enriched meal and then on Day 1 at 45, 90, 120, 150, 180, and 240 minutes post-meal an 8-hour fast on Days -10 to -3 and on Day 14 (±2 days) at 45, 90, 120, 150, 180, 
and 240 minutes starting 30 minutes after study drug administration. Fasting glucose will be assessed before GEBT to ensure a blood glucose level of  275 mg/dL. 
16. 
 
 
 
 
 
17. Sample collected predose. The Day 1 prolactin sample is not required to be repeated if a prolactin was obtained for the pre-randomization visit in the last 72 hours. 
18. Study drug will be dispensed with treatment assigned via IRT on Day 1. 
19. All subjects will take a dose of blinded study drug (CIN-102 or placebo capsules) orally at 
AM 
 and 
PM 
 
 
 
 
 
 
 
 
 

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The evening dose will be self-administered by the subject.  If a subject reports vomiting during the 
treatment period, subjects should attempt to note the time of vomiting in relation to time of study drug administration and report this to site staff during scheduled clinic 
visits. 
20. Study drug accountability will occur on Days 3, 7, 10, and 14 or on Early Termination if applicable. Unused study drug will only be collected on Day 14 (±2 days) or on 
Early Termination if applicable. 
21. For subjects who provide written informed consent to participate in the optional PGx assessment, a blood sample will be collected at any time during the subject’s 
participation in the study. 
22. Subjects participating in the intensive PK subgroup will report to the clinic on Day 15  and on Day 16 (+1 day) where a PK sample will be collected at each respective visit. 
Subjects in the sparse PK subgroup may report to the clinic on either Day 15 or Day 16 (+1 day) and a PK sample will be collected at the selected visit. 
23. For subjects participating in the sparse PK subgroup and are only required to be complete either Day 15 or Day 16 (+1 day) these procedures will be performed on Day 16 
(+1 day) if Day 15 was not performed. Note: electronic diary materials will only be collected if provided to the subject by the Sponsor as applicable. 
 
; BMI = body mass index; 
ECG = electrocardiogram; ET = early termination; FSH = follicle-stimulating hormone; GEBT = gastric emptying breath test; HBsAg = Hepatitis B surface antigen; 
HCV = Hepatitis C virus; HIV = human immunodeficiency virus; I/E = inclusion and exclusion; 
; 
POC = point of care, Severity Index; PK = pharmacokinetic; PGx = pharmacogenomic; TSH = thyroid-stimulating hormone. 
 

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APPENDIX B: CLINICAL LABORATORY ANALYTES 
Standard Safety Chemistry Panel 
Alanine aminotransferase 
Albumin 
Alkaline phosphatase 
Amylase 
Aspartate aminotransferase 
Bicarbonate 
Blood urea nitrogen 
Calcium 
Chloride 
Creatine kinase 
Creatinine 
Estimated glomerular filtration rate 
Gamma-glutamyl transferase 
Glucose 
Inorganic phosphorus 
Lactate dehydrogenase 
Lipase 
Potassium 
Sodium 
Total bilirubin 
Total protein 
Uric acid 
 
Endocrinology 
Follicle-stimulating hormone [1] 
Thyroid-stimulating hormone 
Prolactin 
1. Follicle-stimulating hormone will only be assessed in females who have been 
postmenopausal for at least 1 year and are not surgically sterile. 
 
Hematology 
Hematocrit 
Hemoglobin 
Platelets 
Red blood cell count 
Glycosylated hemoglobin 
 
White blood cell count and differential [1] 
 
1. Manual microscopic review is performed only if white blood cell count and/or 
differential values are out of reference range. 
 
Urinalysis 
Bilirubin 
Blood 
Glucose 
Ketones 
Leukocyte esterase 
Microscopy [1] 
Nitrite 
pH 
Protein 
Specific gravity 
Urobilinogen 
 
1. Microscopy is performed only as needed based on positive dipstick results. 
 

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Serology 
Hepatitis B surface antigen 
Hepatitis C virus antibody 
Human immunodeficiency virus antibody 
 
 
Pregnancy Test 
Serum and point-of-care pregnancy tests will only be performed in females who are not 
surgically sterile (or postmenopausal for at least 1 year [with confirmed FSH in postmenopausal 
range at the Screening Visit]). 
 
Urine Drug Screen [1] 
Amphetamines 
Cocaine 
Cotinine 
Opiates 
Phencyclidine 
Tetrahydrocannabinol 
1. Urine drug screen point of care drug test on randomization day.  
 
Breath Alcohol Test 
 
 

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APPENDIX C: ELECTROCARDIOGRAM ALERT CRITERIA 
GUIDANCE 
Investigators should contact the Sponsor or designee if any clinically meaningful changes 
from baseline ECGs, including but not limited to those listed below, are noted upon review. 
• QTcF ≥450 msec (male) 
• QTcF ≥470 msec (female) 
• A > 60 msec increase in QTcF from baseline 
• A 6% or greater increase in QTcF from baseline 
New onset findings including but not limited to the following: 
• Second degree AV block (Mobitz II) 
• Third degree AV block (complete heart block) 
• Acute myocardial infarction 
• New left bundle branch block (LBBB) 
• Severe bradycardia (ventricular rate ≤40 bpm) 
• Supraventricular tachycardia (SVT) (ventricular rate ≥150 bpm) 
• Torsades de pointes 
• Ventricular tachycardia (Three or more beats regardless of rate) 
• Ventricular fibrillation 
• Atrial fibrillation/atrial flutter (ventricular rate ≥150 bpm)