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.

 
 
C LI NI C A L S T U D Y P R O T O C O L 
 
A R a n d o mize d, D o u ble- Bli n d, Pl a ce b o- C o ntr olle d St u d y t o E v al u ate 
t he S afet y, Effic a c y, P h a r m ac o ki netics, a n d D ose Res p o nse of Or al 
CI N- 1 0 2 i n A d ults wit h Di a betic G astr o p aresis 
I n v esti g ati o n al Pr o d uct: CI N- 1 0 2 
Pr ot oc ol N u m ber:  CI N- 1 0 2- 1 2 1 
 
 
 
S p o ns or: 
Ci n D o m e P h ar m a, I nc. 
5 3 7 5 Me d pace Wa y 
Ci n ci n nati, O H 4 5 2 2 7 
U nite d States 
 
 
 
 
 
Versi o n N u m b er:  2. 0 
Ori gi n al Pr ot oc ol: 1 9 M a y 2 0 1 9  
Versi o n 2. 0, A me n d me nt 1: 1 5 A u g 2 0 1 9 
 
 
C o nfi d e nti alit y St ate me nt 
T he i nf or mati o n i n t his d oc u me nt is c o nfi de ntial a n d is n ot t o b e dis cl os e d wit h o ut t he writte n 
c o nse nt of Ci n D o me P har ma, I nc. e x ce pt t o t he e xte nt t hat discl os ure w o ul d be re q uire d b y la w 
a n d f or t he p ur p ose of e v al uati n g a n d/ or c o n d u cti n g a cli nical st u d y f or Ci n D o me P har ma, I n c. 
Y o u are all o we d t o discl ose t he c o nte nts of t his d oc u me nt o nl y t o y o ur I nstit uti o nal Re vie w B oar d 
a n d st u d y pers o n n el directl y i n v ol ve d wit h c o n d ucti n g t his pr ot oc ol. Pers o ns t o w h o m t he 
i nf or mati o n is discl ose d m ust b e i nf or me d t hat t h e i nf or mati o n is c o nfi d e ntial a n d pr o prietar y t o 
Ci n D o m e P h ar m a, I nc. a n d t hat it ma y n ot be f urt her discl ose d t o t hir d parties. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
3
I N V E S TI G A T O R A G R E E M E N T 
B y si g ni n g b el o w, I a gree t h at: 
I h a ve rea d t his pr ot oc ol. I a p pr o ve t his d oc u me nt a n d I a gree t h at it c o ntai ns all necessar y details 
f or carr yi n g o ut t he st u d y as descri be d. I will c o n d uct t his st u d y i n acc or da n ce wit h t he desi g n a n d 
s pecific pr o visi o n of t his pr ot o c ol a n d will ma ke a reas o n a ble eff ort t o c o m plete t he st u d y wit hi n 
t he ti me desi g nat e d. I will pr o vi de c o pies of t his pr ot oc ol a n d access t o all i nf or mati o n f ur nis he d 
b y Ci n D o m e P har ma, I n c. t o st u d y pers o n nel u n der m y s u p er visi o n. I will disc uss t his material 
wit h t h e m t o e ns ure t h e y are f ull y i nf or m e d a b o ut t he st u d y pr o d u ct a n d st u d y pr oce d ures. I will 
let t he m k n o w t h at t his i nf or mati o n is c o nfi de ntial a n d pr o prietar y t o Ci n D o me P har ma, I nc. a n d 
t hat it ma y n ot be f urt her discl ose d t o t hir d parti es. I u n d ersta n d t hat t he st u d y m a y b e ter mi nate d 
or e nr oll me nt s us pe n d e d at a n y ti m e b y Ci n D o me P h ar m a, I nc., wit h or wit h o ut ca use, or b y me if 
it b ec o mes necessar y t o pr otect t he best i nterests of t h e st u d y p atie nts. 
I a gree t o c o n d uct t his st u d y i n f ull acc or da nce wit h F o o d a n d Dr u g A d mi nistrati o n Re g ulati o ns, 
I nstit uti o nal 
Re vie w 
B oar d/ Et hic 
C o m mittee 
Re g ulati o ns a n d I nter n ati o nal 
C o u ncil f or 
Har m o nisati o n G ui deli nes f or G o o d Cli nical Practi ces. 
 
 
 
 
 
 
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I n v esti gat or’s Si g n at ure  
  
  
  
  
  
Date 
 
 
 
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I n v esti gat or’s Pri nte d Na me 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
4
S Y N O P SI S 
TI T L E:   A Ra n d o mize d, D o u ble- Bli n d, Place b o-C o ntr olle d St u d y t o E val uate t he Safet y, 
Efficac y, P h ar mac o ki neti cs, a n d D ose Res p o nse of Oral CI N- 1 0 2 i n A d ults wit h Dia betic 
Gastr o paresis 
P R O T O C O L N U M B E R:   CI N- 1 0 2- 1 2 1 
I N V E S TI G A TI O N A L P R O D U C T:  CI N- 1 0 2 
P H A S E:   2 A 
I N DI C A TI O N:  Treat m e nt a n d relief of s y m pt o ms ass ociate d wit h ac ute a n d rec urre nt 
gastr o p aresis 
O B J E C TI V E S: 
T he o bjecti ves of t his st u d y are t he f oll o wi n g: 
 T o e val uate t he safet y a n d t olera bilit y of m ulti ple d oses of CI N- 1 0 2 i n patie nts wit h dia betic 
gastr o p aresis 
 T o e val uate t he effect of m ulti ple d oses of CI N- 1 0 2 o n gastric e m pt yi n g as meas ure d b y t he 
gastri c e m pt yi n g breat h t est ( G E B T) i n patie nts wit h dia betic gastr o paresis 
 T o c haracterize t he p har mac o ki neti c ( P K) of m ulti ple d oses of CI N- 1 0 2 i n p atie nts wit h 
dia beti c gastr o paresis 
T he e x pl orat or y o bj ecti v es of t his st u d y i ncl u de t he f oll o wi n g: 
 T o assess t he effect of m ulti ple d oses of CI N- 1 0 2 o n na usea ass o ciate d wit h gastr o paresis 
base d o n t he na us ea sc ore o n t h e A merica n N e ur o gastr oe nt er ol o g y a n d M otilit y S ociet y 
Gastr o paresis Car di nal S y m pt o m I n de x Dail y Di ar y ( A N M S G C SI- D D) 
 T o assess t he effect of m ulti ple d oses of CI N- 1 0 2 o n A N M S G C SI- D D sc ores (t otal a n d 
s u bscales) i n patie nts wit h dia betic gastr o paresis 
 T o assess t he effect of m ulti ple d oses of CI N- 1 0 2 o n a variet y of p atie nt re p orte d o utc o mes 
 T o c haracteriz e e x p os ure-res p o nse relati o ns hi ps of CI N- 1 0 2 
P O P U L A TI O N: 
T he p o p ulati o n f or t his st u d y is a d ult patie nts 1 8 t o 7 0 ye ars ol d wit h T y p e 1 or T y pe 2 i ns uli n  
de pe n de nt- dia b etes mellit us, acc or di n g t o t he A m erica n Di a betes Ass ociati o n criteria, a n d a 
dia g n osis of dia betic gastr o paresis d efi ne d b y u p p er gastr oi ntesti nal s y m pt o ms felt t o b e c o nsiste nt 
wit h gastr o p aresis or pre vi o usl y d oc u me nte d d ela ye d gastric e m pt yi n g.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
1 1  
T A B L E O F C O N T E N T S 
Si g nat ure Pa ge ................................................................................................................................ 2  
I n v esti gat or A gree me nt ................................................................................................................... 3 
S y n o psis .......................................................................................................................................... 4  
Ta ble of C o nte nts .......................................................................................................................... 1 1  
List of T a bl es ................................................................................................................................ 1 5  
List of Fi g ures ............................................................................................................................... 1 6  
List of A b bre viati o ns a n d Defi niti o n of Ter ms............................................................................. 1 7  
1  I ntr o d u cti o n a n d Bac k gr o u n d I nf or mati o n ............................................................................. 1 9 
1. 1  
I n dicati o n a n d Treat m e nt O pti o ns ................................................................................. 1 9 
1. 2  
CI N- 1 0 2 ......................................................................................................................... 2 0  
1. 3  
St u d y R ati o nale ............................................................................................................. 2 1  
1. 4  
Ris k/ Be nefit ................................................................................................................... 2 1  
2  St u d y O bjecti v es ..................................................................................................................... 2 3  
2. 1  
O bjecti v es ...................................................................................................................... 2 3  
2. 2  
E x pl orat or y O bjecti v es .................................................................................................. 2 3  
3  St u d y Descri pti o n.................................................................................................................... 2 4  
3. 1  
S u m mar y of St u d y Desi g n ............................................................................................ 2 4  
3. 2  
St u d y I n dicati o n ............................................................................................................ 2 5  
3. 3  
D ose Escalati o n a n d R e vie w C o m mittee ...................................................................... 2 6  
3. 3. 1  Criteria f or T e m p orar y S us p e nsi o n of D osi n g .................................................. 2 6  
3. 3. 2  Criteria t o Cease D os e Escalati o n ..................................................................... 2 7  
4  Selecti o n a n d Wit h dra wal of Patie nts ..................................................................................... 2 8  
4. 1  
I n cl usi o n Criteria ........................................................................................................... 2 8 
4. 2  
E x cl usi o n Criteria .......................................................................................................... 2 9  
4. 3  
Ra n d o mizati o n Criteria ................................................................................................. 3 1  
4. 4  
Wit h dra wal Criteria ....................................................................................................... 3 2  
5  St u d y Treat me nts .................................................................................................................... 3 3  
5. 1  
Treat m e nt Gr o u ps .......................................................................................................... 3 3  
5. 2  
Rati o nale f or D osi n g ..................................................................................................... 3 3  
5. 3  
Ra n d o mizati o n a n d Bli n di n g ......................................................................................... 3 4  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
1 2  
5. 4  
Brea ki n g t he Bli n d ........................................................................................................ 3 4  
5. 5  
Dr u g S u p plies ................................................................................................................ 3 4  
5. 5. 1  F or m ulati o n a n d Pac k a gi n g ............................................................................... 3 4  
5. 5. 2  St u d y Dr u g Pre parati o n a n d Dis pe nsi n g ........................................................... 3 4  
5. 5. 3  St u d y Dr u g A d mi nistrati o n ............................................................................... 3 4  
5. 5. 4  Treat m e nt C o m plia nce ...................................................................................... 3 5  
5. 5. 5  St ora ge a n d A cc o u nta bilit y ............................................................................... 3 5  
5. 6  
Pri or a n d C o nc o mita nt Me dicati o ns a n d/ or Pr oce d ures ................................................ 3 5  
5. 6. 1  E x cl u de d Me dicati o ns, F o o ds, a n d/ or Pr oce d ures ............................................ 3 5  
5. 6. 2  Restricte d Me dicati o ns a n d/ or Pr oce d ures ........................................................ 3 6  
5. 6. 3  All o we d Me dicati o ns a n d/ or Pr oce d ures .......................................................... 3 6  
5. 6. 4  D oc u m e ntati o n of Pri or a n d C o nc o mita nt Me dicati o n Use .............................. 3 6  
6  St u d y Pr o ce d ures .................................................................................................................... 3 7  
6. 1  
I nf or me d C o nse nt .......................................................................................................... 3 7 
6. 2  
P har mac o ge n o mic Ass ess me nts .................................................................................... 3 7  
6. 3  
Scree ni n g Visit ( Da ys - 2 8 t o - 8) ................................................................................... 3 7  
6. 4  
Baseli ne Gastric E m pt yi n g Breat h Test Visit ( Da ys - 7 t o - 2) ....................................... 3 8  
6. 5  
Ra n d o mizati o n ( Da y - 1 or Da y 1) ................................................................................. 3 8  
6. 6  
Treat m e nt Peri o d – D a ys 1 t o 1 5 ................................................................................... 4 0  
6. 6. 1  Da y 1 ................................................................................................................. 4 0  
6. 6. 2  Da y 2 ................................................................................................................. 4 1  
6. 6. 3  Da y 3 ( ± 1 Da y) .................................................................................................. 4 1  
6. 6. 4  Da ys 4 t o 6 ......................................................................................................... 4 2  
6. 6. 5  Da y 7 ( ± 1 Da y) .................................................................................................. 4 2  
6. 6. 6  Da ys 8 t o 9 ......................................................................................................... 4 3  
6. 6. 7  Da y 1 0 ( ± 1 Da y) ................................................................................................ 4 3  
6. 6. 8  Da ys 1 1 t o 1 3 ..................................................................................................... 4 4  
6. 6. 9  Da y 1 4 ( ± 2 Da ys) .............................................................................................. 4 4  
6. 6. 1 0  Da y 1 5 ............................................................................................................... 4 5  
6. 7  
F oll o w- u p Visit ( Da ys 1 6 or 1 7) ................................................................................... 4 5  
6. 8  
Earl y Ter mi nati o n Visit a n d Wit h dra wal Pr oce d ures ................................................... 4 6  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
1 3  
7  Efficac y Assess me nts.............................................................................................................. 4 7  
7. 1  
Pri mar y Efficac y Assess me nt ........................................................................................ 4 7  
7. 2  
Sec o n dar y Efficac y Assess m e nt .................................................................................... 4 7  
7. 3  
E x pl orat or y Efficac y Assess m e nt ................................................................................. 4 7  
7. 4  
P har mac o ki n etics .......................................................................................................... 4 8  
7. 5  
P har mac o ge n o mic Ass ess me nts .................................................................................... 4 9  
7. 5. 1  C oll ecti o n, St ora ge, a n d Destr ucti o n of P har mac o ge n o mic Sa m ples ............... 4 9  
8  Safet y Assess m e nts ................................................................................................................. 5 0  
8. 1  
A d vers e E v e nts .............................................................................................................. 5 0  
8. 1. 1  A d vers e ( Dr u g) Re acti o n .................................................................................. 5 1  
8. 1. 2  U ne x pecte d A d verse Dr u g R eacti o n ................................................................. 5 1  
8. 1. 3  Assess me nt of A d vers e E ve nts b y t h e I n vesti gat or .......................................... 5 1  
8. 2  
Seri o us A d vers e E v e nts ................................................................................................. 5 2  
8. 3  
Seri o us A d vers e E v e nt Re p orti n g − Pr oce d ures f or I n vesti gat ors ................................ 5 3  
8. 4  
Pre g n a nc y Re p orti n g ..................................................................................................... 5 4  
8. 5  
E x pe dite d Re p orti n g ...................................................................................................... 5 4  
8. 6  
Cli nical La b orat or y E val uati o ns .................................................................................... 5 4  
8. 7  
Vital Si g ns ..................................................................................................................... 5 5  
8. 8  
Electr ocar di o gra ms ........................................................................................................ 5 5  
8. 9  
P h ysical E x a mi nati o ns .................................................................................................. 5 6  
8. 1 0  Hei g ht a n d Wei g ht ........................................................................................................ 5 6  
9  Statistics .................................................................................................................................. 5 7  
9. 1  
A nal ysis P o p ulati o ns ..................................................................................................... 5 7  
9. 2  
Statistical M et h o ds ........................................................................................................ 5 7  
9. 2. 1  A nal ysis of Efficac y .......................................................................................... 5 7  
9. 2. 1. 1  Pri mar y efficac y a nal ysis .................................................................... 5 7  
9. 2. 1. 2  Sec o n dar y efficac y a n al ysis ................................................................ 5 7  
9. 2. 1. 3  E x pl orat or y efficac y a nal ysis .............................................................. 5 7  
9. 2. 1. 4  P har mac o ki n etic a nal ysis .................................................................... 5 8  
9. 2. 1. 5  P har mac o ki n etic- P har mac o d y n a mic a n al ysis ..................................... 5 8  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
1 4  
9. 2. 2  A nal ysis of Safet y ............................................................................................. 5 8  
9. 2. 3  I nteri m A nal ysis ................................................................................................ 5 8 
9. 2. 4  Sa m ple Size Deter mi nati o n ............................................................................... 5 8  
1 0  Data Ma na g e me nt a n d R ec or d K ee pi n g ................................................................................. 5 9  
1 0. 1  Data Ma na g e me nt ......................................................................................................... 5 9  
1 0. 1. 1  Data Ha n dli n g ................................................................................................... 5 9  
1 0. 1. 2  C o m p uter S yst e ms ............................................................................................. 5 9  
1 0. 1. 3  Data E ntr y ......................................................................................................... 5 9  
1 0. 1. 4  Me dical I nf or mati o n C o di n g ............................................................................. 5 9  
1 0. 1. 5  Data Vali dati o n ................................................................................................. 5 9  
1 0. 2  Rec or d Kee pi n g ............................................................................................................. 5 9  
1 1  I n v esti gat or Re q uire me nts a n d Q ualit y C o ntr ol ..................................................................... 6 0 
1 1. 1  Et hical C o n d uct of t he St u d y ........................................................................................ 6 0  
1 1. 2  I nstit uti o nal Re vie w B oar d ............................................................................................ 6 0 
1 1. 3  I nf or me d C o nse nt .......................................................................................................... 6 0 
1 1. 4  St u d y M o nit ori n g R e q uir e me nts ................................................................................... 6 0  
1 1. 5  Discl os ure of D ata ......................................................................................................... 6 1  
1 1. 6  Rete nti o n of Rec or ds ..................................................................................................... 6 1  
1 1. 7  P u bli cati o n P olic y ......................................................................................................... 6 1  
1 1. 8  Fi na ncial Discl os ure ...................................................................................................... 6 2  
1 2  St u d y A d mi nistrati ve I nf or mati o n .......................................................................................... 6 3  
1 2. 1  Pr ot oc ol A me n d me nts ................................................................................................... 6 3  
1 3  Refere n ces ............................................................................................................................... 6 4  
A p pe n di x A:  Sc he d ule of Pr oce d ures .......................................................................................... 6 6  
A p pe n di x B: Cli nical La b orat or y A nal ytes .................................................................................. 6 9  
A p pe n di x C: Electr ocar di o gra m Alert Criteria G ui da nce ............................................................ 7 1  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
1 5  
LI S T O F T A B L E S 
Ta ble 1.     C T C A E Se verit y Assess me nt of A d verse E ve nts ....................................................... 5 1  
Ta ble 2.  
Sc he d ule of Pr oce d ures ............................................................................................... 6 6  
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
1 6  
LI S T O F FI G U R E S 
Fi g ure 1.  St u d y Sc h e mati c.......................................................................................................... 2 5  
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
1 7  
LI S T O F A B B R E VI A TI O N S A N D D E FI NI TI O N O F T E R M S  
A b bre viati o n 
Defi niti o n 
 
 
  
  
 
 
A L T 
Ala ni ne a mi n otra nsferase 
A S T 
As partate a mi n otra nsferase 
A U C 
Area u n d er t h e plas ma c o nce ntrati o n-ti me c ur ve 
A V 
Atri o ve ntric ular 
BI D 
T wice dail y 
B MI 
B o d y mass i n de x 
B P M 
Beats p er Mi n ute 
B T ½  
Gastric E m pt yi n g Breat h Test t 1/ 2 ( B T t 1/ 2) 
C ma x  
Ma xi m u m pl as ma c o nce ntrati o n 
C K D- E PI 
C hr o nic Ki d ne y Disease E pi de mi ol o g y C olla b orati o n 
C F R 
C o de of Fe d eral Re g ul ati o ns 
C N S 
C e ntral ner v o us s yste m 
 
 
C R A 
Cli nical Researc h Ass o ciate 
C T C A E 
C o m m o n Ter mi n ol o g y Criteria f or A d vers e E ve nts 
C Y P 
C yt o c hr o me P 4 5 0 
D G E 
Dela ye d g astric e m pt yi n g 
D R C 
Data Re vie w C o m mittee  
E C G 
Electr ocar di o gra m 
e C R F 
Electr o nic case re p ort f or m 
E D C 
Electr o nic data ca pt ure 
e G F R 
Esti mate d gl o mer ular filtrati o n rat e 
EI U 
E x p os ure I n Uter o 
F D A 
F o o d a n d Dr u g A d mi nistrati o n 
F S H 
F ollicle-sti m ulati n g h or m o ne 
G C P 
G o o d Cli nical Practi ce 
G E B T 
Gastric e m pt yi n g breat h test 
GI 
Gastr oi ntesti nal 
 
 
H Bs A g 
He patitis B s urface a nti ge n 
H C V 
He patitis C vir us 
HI V 
H u ma n i m m u n o deficie nc y vir us 
I C F 
I nf or m e d c o ns e nt f or m 
I C H 
I nter nati o nal C o u ncil f or Har m o nis ati o n 
I R B 
I nstit uti o nal Re vie w B oar d 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
1 8  
A b bre viati o n 
Defi niti o n 
I R T 
I nteracti ve Res p o nse Tec h n ol o g y 
I V 
I ntr a ve n o us 
L B B B 
Left B u n dle Bra nc h Bl o c k 
M A D 
M ulti ple-asce n di n g d ose 
MI T T 
M o difie d I nte nt-t o- Treat 
M S E C 
Millis ec o n d(s) 
 
 
P D 
P har mac o d y na mic(s) 
P E G 
Perc uta ne o us e n d osc o pic gastr ost o m y 
P G x 
P har mac o ge n o mic 
P K 
P har mac o ki netic(s) 
P O C 
P oi nt- of-care 
P P 
Per- Pr ot oc ol  
Q Tc F 
Heart rate-c orrecte d Q T i nter val usi n g Fri dericia’s f or m ula 
S A D 
Si n gle-as ce n di n g d ose 
S A E 
Seri o us a d verse e ve nt 
 
 
S V T 
S u pra ve ntric ular t ac h ycar dia 
T ½  
Ter mi n al p hase eli mi nati o n half-life 
T S H 
T h yr oi d-sti m ulati n g h or m o ne 
U L N 
U p per li mit of n or mal 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
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1  
I N T R O D U C TI O N A N D B A C K G R O U N D I N F O R M A TI O N  
1. 1  
I n dic ati o n a n d T re at me nt O pti o ns 
Gastr o paresis is d efi n e d as i m p aire d gastric e m pt yi n g i n t he a bse nce of p h ysical gastric o utlet 
o bstr ucti o n. S y m pt o ms i ncl u de earl y s atiet y, p ost pra n dial f ull ness, na usea, v o miti n g, a n d 
a b d o mi nal pai n. 1 T he disease is ofte n ass ociate d wit h dia betes or ma y occ ur after gastric s ur ger y; 
it m a y als o be i di o pat hic fr o m u n k n o w n eti ol o gies.2 Gastr o paresis affects t he patie nt’s n utriti o nal 
state, es p eciall y i n dia beti cs, a n d se vere s y m pt o ms of gastr o p aresis ca n le a d t o ot her c o m plicati o ns 
s uc h as mal n utriti o n, es o p ha gitis, a n d Mall or y- Weiss tears. 3 ,4 Gastr o paresis ne gati vel y i m p acts 
a patie nt’s q ualit y of life, ca usi n g decrease d s o cial i nteracti o n, p o or w or k f u ncti o nalit y, a n d 
de vel o p me nt of a n xiet y or de pressi o n. 3 
T he first-li n e treat me nt f or gastr o paresis i n v ol v es n utriti o nal ma na ge me nt a n d s u p p ort, i ncl u di n g 
fl ui d a n d electr ol yte re place me nt. P h ar mac ol o gic t hera p y is directe d at i ncreasi n g gastric e m pt yi n g 
a n d accelerati n g i ntesti n al tra nsit ti m e. C urre ntl y, met ocl o pra mi de, a d o pa mi n e D 2 rece pt or 
a nta g o nist, is t he o nl y U nite d States F o o d a n d Dr u g A d mi nistrati o n ( F D A)-a p pr o ve d a ge nt f or t h e 
treat me nt of gastr o p aresis. 
W hil e effecti ve, t his a ge nt rea dil y cr osses t he bl o o d- brai n barrier 
res ulti n g i n ce ntral ner v o us s yst e m ( C N S) si de effects i n u p t o 4 0 % of patie nts. 5 C o m m o n C N S 
effects ass ociate d wit h met ocl o pra mi de treat me nt i n cl u de restl ess ness, dr o wsi ness, fati g u e, a n d 
lassit u de; h o we ver, t h e m aj or safet y c o ncer n wit h met o cl o pra mi de treat m e nt is t he d e vel o p me nt 
of tar di v e d ys ki nesia. Tar di ve d ys ki nesia is a dis or der c haracterize d b y i n v ol u ntar y m o ve me nts of 
t he face, t o n g u e, or e xtre mities a n d is ofte n irre v ersi ble. I n crease d ris k of de v el o pi n g tar di ve 
d ys ki n esia c orrelates t o treat me nt d urati o n; t h eref ore, it is rec o m m e n d e d t hat t h era p y wit h 
met ocl o pra mi d e n ot e xcee d 1 2 wee ks. 6  
D o m peri d o ne is a p eri p heral d o p a mi n e D 2 rece pt or a nta g o nist t hat acts as a n a ntie metic a n d 
a pr o ki netic a ge nt t hr o u g h its effects o n t he c he m orece pt or tri g ger z o ne i n t he area p ostre m a a n d 
t he m ot or f u ncti o n i n t he st o m ac h a n d s mall i ntesti ne.7 ,8 D o m peri d o ne has bee n a vaila ble 
w orl d wi de o utsi de of t he U nite d States si nce 1 9 7 8 as a treat m e nt f or gastr o paresis as well as 
a ge neral a ntie metic. It is c urre ntl y a v aila ble i n 5 8 c o u ntries, i ncl u di n g C a na da. I n t h ose c o u ntri es 
w here d o m peri d o ne is a p pr o ve d, t he c urre nt rec o m m e n de d dail y d ose is u p t o 3 0 m g/ da y ( 1 0 m g 
a d mi nistere d orall y 3 ti mes a d a y) f or na usea a n d v o miti n g. W hile a vaila ble i n ma n y c o u ntries 
w orl d wi de, d o m peri d o n e is o nl y a vaila ble t o pati e nts i n t he 
U nite d 
St ates t hr o u g h 
a p h ysici a n-i nitiate d I n v esti gati o nal N e w Dr u g a p plicati o n at d oses u p t o 1 2 0 m g/ d a y ( 3 0 m g 
a d mi nistere d orall y 4 ti m es per da y) f or t he treat me nt of gastr o paresis a n d a n y c o n diti o n ca usi n g 
c hr o nic na us ea a n d v o miti n g. 8 C urre nt treat me nt g ui deli nes rec o m m e n d t h e use of d o m p eri d o n e 
f or p atie nts u na ble t o use met ocl o pra mi d e.9  
U nli ke met ocl o pra mi d e, d o m p eri d o ne d oes n ot cr oss t h e bl o o d- brai n barrier a n d sel d o m ca uses 
e xtra p yra mi d al si d e effects. Si milar t o ot her d o pa mi ne D 2 rece pt or a nta g o nists, d o m peri d o ne has 
bee n s h o w n t o raise pr olacti n le vels wit h c hr o ni c a d mi nistrati o n, b ut pr olacti n le vels ret ur n t o 
n or mal u p o n disc o nti n uati o n of t h e dr u g. 7, 1 0 Use of d o m peri d o ne has als o bee n ass ociate d wit h 
Q T pr ol o n gati o n. D ue t o re p orts of car diac arrest wit h t he use of i ntra ve n o us (I V) d o m peri d o ne, 
t he I V d ose f or m was re m o ve d fr o m t he mar ket. Gi ve n t he l o w oral bi oa vaila bilit y of d o m peri d o ne 
(a p pr o xi m atel y 1 3 % t o 1 7 % of t h e a d mi nistere d d ose),8 oral d oses i n e xcess of 1 0 0 0 m g/ da y w o ul d 
c orrel ate wit h t he I V d oses a d mi nistere d t o patie nts at t he ti me w he n t he car di ac iss ues w ere 
re p orte d.1 1 W h e n Q T pr ol o n gati o n h as bee n re p orte d wit h oral d o m peri d o ne, it has pri maril y bee n 
i n patie nts o ver 6 0 years of a ge, i n p atie nts ta ki n g m ore t ha n 3 0 m g/ da y, i n patie nts wit h car di ac 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
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pre dis p ositi o ns, or i n patie nts w h o were als o recei vi n g ot her Q T- pr ol o n gi n g dr u gs or p ote nt 
c yt o c hr o m e P 4 5 0 ( C Y P) 3 A 4 i n hi bit ors, s uc h as k et oc o naz ole. H o w e ver, t here h a ve b ee n re p orts 
of cas es of Q T pr ol o n gati o n a m o n g patie nts ta ki n g d o m peri d o ne wit h n o ne of t hese a d diti o nal ris k 
fact ors.1 2 ,1 3 T he p ote ntial f or Q T pr ol o n gati o n is belie ve d t o be relate d t o i ncreas e d plas ma 
c o nce ntr ati o ns of d o m peri d o ne. It is s u g geste d t hat t he mea n effect o n Q T of 1 0 msec (t h e 
defi niti o n of Q T pr ol o n gati o n) m a y o cc ur w he n t he d o m p eri d o ne plas ma c o nce ntr ati o n reac hes 
a p pr o xi matel y 6 5 n g/ m L. 1 4 ,1 5 T heref ore, li miti n g t he ma xi m u m plas ma c o nce ntrati o n ( Cma x ) of 
d o m peri d o ne t o a p pr o xi m atel y 6 0 n g/ m L ma y si g nifica ntl y l o w er t h e ris k of Q T pr ol o n gati o n. 
1. 2  
CI N- 1 0 2 
Ci n D o m e P h ar m a, I n c. is c urre ntl y de vel o pi n g CI N- 1 0 2, a de ut erate d f or m of d o m peri d o ne. 
A ne w pr ocess was d e v el o pe d t o s y nt hesize a de uterate d v ersi o n of d o m peri d o ne  
 
 
 
 
Gi v e n t h at t he 
p har mac ol o gical pr o perties of CI N- 1 0 2 are si milar t o t h ose of d o m p eri d o ne, CI N- 1 0 2 is i nte n d e d 
t o pr o vi de a n alter nati v e f or t he treat me nt a n d relief of s y m pt o ms ass o ciate d wit h ac ute a n d 
rec urre nt gastr o p aresis t h at ma y h a ve l ess p ote ntial f or Q T pr ol o n gati o n. 
T w o cli nical st u dies of CI N- 1 0 2 i n healt h y s u bjects ha ve c o m me nce d t o date: a si n gle-asce n di n g 
d ose ( S A D) st u d y ( St u d y 
CI N- 1 0 2- 1 1 1) a n d a 
m ulti ple-asce n di n g d ose ( M A D) st u d y 
( St u d y CI N- 1 0 2- 1 1 2). 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
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1. 3  
St u d y R at i o n ale 
T o date, t h e P K, p har mac o d y na mics ( P D; bas e d o n i ncreases i n pr olacti n), a n d safet y of CI N- 1 0 2 
ha ve bee n e val uate d i n a S A D st u d y a n d a M A D st u d y i n healt h y s u bjects. T he c urre nt st u d y is 
t he first st u d y i n p atie nts wit h gastr o p aresis. As s uc h, t his st u d y is i nte n de d t o e val uate t h e effect 
of CI N- 1 0 2 o n gastric e m pt yi n g i n patie nts wit h dia betic gastr o p aresis o v er a ra n ge of d os es. T he 
safet y, P K, a n d effect of CI N- 1 0 2 o n s y m pt o ms of gastr o p aresis i n t hese p atie nts will als o be 
assess e d i n t his pr o of of c o nce pt st u d y. T h e res ults of t his st u d y will be use d t o s u p p ort d ose 
selecti o n f or f ut ure st u dies.  
1. 4  
Ris k/ Be nefit 
Si d e effects t hat ha v e b ee n re p orte d b y 1 % of patie nts treate d i n cli nical tri als wit h d o m peri d o ne 
wit h a me dia n t otal dail y d ose of 8 0 m g i ncl u de t he f oll o wi n g: de pressi o n, a n xiet y, l oss of li bi d o, 
hea dac he, s o m n ole nce, a kat hisia, diarr h ea, ras h, pr urit us, g y nec o mastia, breast te n d er ness, 
gal act orr h ea, a me n orr hea, breast p ai n, irre g ular m e nstr uati o n, lactati o n dis or ders, a n d ast h e ni a. 7 
Less fre q u e ntl y re p orte d a d verse e ve nts t hat occ urre d i n < 1 % of treate d p atie nts i ncl u de 
h y perse nsiti vit y, urticari a, breast disc har ge, a n d breast s w elli n g. 7 Rare or ver y rare a d v erse 
reacti o ns t hat ha ve bee n esti mate d fr o m s p o nta ne o us re p orti n g i ncl u de a na p h yl acti c reacti o ns, 
a gitati o ns, n er v o us ness, e xtra p yra mi dal dis or ders, c o n v ulsi o ns, s u d de n car diac deat h, ve ntric ul ar 
arr h yt h mias, a n gi oe d e ma, uri nar y rete nti o n, a b n or mal li ver tests, a n d i n crease d bl o o d pr olacti n. 7 
As n ote d pre vi o usl y, d o m peri d o ne has bee n ass o ciate d wit h pr ol o n gati o n of t he Q T i nter val o n 
electr ocar di o gra ms ( E C Gs). 1 6 D uri n g p ost mar k eti n g s ur v eilla nce, t h ere ha ve bee n ver y rare cases 
( < 1/ 1 0, 0 0 0 cases) of Q T pr ol o n gati o n a n d Q T pr ol o n gati o n-i n d uce d T orsa des d e P oi ntes i n 
patie nts ta ki n g oral d o m peri d o ne. 1 6, 1 7 T hese re p orts i ncl u de d patie nts wit h c o nf o u n di n g ris k 
fact ors, electr ol yt e a b n or malities, a n d c o nc o mita nt treat me nt, w hic h ma y h a ve bee n c o ntri b uti n g 
fact ors.1 7 E pi de mi ol o gical st u dies s h o we d t hat d o m peri d o ne was ass ociate d wit h a n i ncrease d ris k 
of seri o us ve ntric ular arr h yt h mias or s u d de n car diac deat h. 1 6 A hi g her ris k was o bs er ve d wit h 
I V a d mi nistrati o n a n d f oll o wi n g oral a d mi nistrati o n i n patie nts ol der t ha n 6 0 years, patie nts ta ki n g 
t otal dail y oral d oses greater t h a n 3 0 m g, a n d p atie nts c o nc urre ntl y ta ki n g Q T- pr ol o n gi n g dr u gs or 
C Y P 3 A 4 i n hi bit ors. 1 1 ,1 2 H o we ver, t here h a ve b ee n re p orts of cases of Q T pr ol o n gati o n i n patie nts 
ta ki n g d o m peri d o ne wit h n o ne of t hese a d diti o nal ris k fact ors.1 2, 1 3 Fr o m a re vi e w of t he lit erat ure, 
i ncl u di n g a n ass ess me nt of t he t h or o u g h Q T a n d case-c o ntr olle d st u dies wit h res pect t o t h e 
i nci de nce of Q T pr ol o n gati o n a n d s u d de n car diac deat h, t he data a p pear t o i n dicat e t hat t h e ris k of 
Q T pr ol o n gati o n is relate d t o t he i ncreas e d plas ma le vels of d o m p eri d o n e. 1 1, 1 4 ,1 8 A d diti o nall y, t h e 
F D A E x pa n d e d Access t o I n vesti gati o nal Dr u gs pr o gra m we bsite f or re q uesti n g d o m p eri d o ne 
i n dicates t hat t he seri o us ris ks ass ociate d wit h d o m peri d o ne are relate d t o d o m peri d o ne le vels i n 
t he bl o o d, a n d hi g h er d o m peri d o ne bl o o d le vels are ass ociat e d wit h hi g h er ris k of t hese e ve nts.1 9 
Ot her st u d y-relat e d ris ks i ncl u de t h ose ass ociate d wit h bl o o d dra ws, s uc h as disc o mf ort, br uisi n g, 
i nfecti o n, blee di n g, p ai n, re d ness at t he p u nct ure site, a n d/ or li g ht hea de d ness, as well as te m p orar y 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
2 2  
disc o mf ort, re d ness, or ras h at t he sit e of E C G electr o de place me nt, a n d dizzi ness, hea dac he, 
st o mac h dis c o mf ort, or fai nti n g d ue t o fasti n g. 
T he d oses pla n ne d f or i n cl usi o n i n t his st u d y were c h ose n bas e d u p o n t he s afet y, t olera bilit y, a n d 
P K pr ofile esta blis he d i n t h e P h ase 1 S A D a n d M A D st u dies. T he mea n C ma x  of 4 8. 1 8 n g/ m L 
o bser ve d i n healt h y s u bj ects rec ei vi n g 6 0 m g BI D (t he hi g hest pr o p ose d d osi n g re gi me n f or t he 
c urre nt st u d y) is  bel o w t h e hi g hest o bser ve d mea n C ma x  fr o m t he 1 2 0 m g si n gle d ose ( 9 6. 8 n g/ m L), 
a d ose t h at was well-t olerate d b y healt h y s u bjects wit h n o cli nicall y mea ni n gf ul Q T pr ol o n gati o n.  
Gi ve n t he ass oci ati o n of Q T pr ol o n gati o n a n d d o m peri d o ne, p atie nts partici pati n g i n t his st u d y 
will be m o nit ore d cl osel y f or a d v erse e ve nts, i ncl u di n g t h ose t h at ha v e bee n re p orte d wit h 
d o m peri d o ne, a n d 1 2-l ea d E C Gs will be c ollecte d at eac h visit t o t he cli nic.  
A g oal of t his st u d y is t o assess t he effect of CI N- 1 0 2 o n gastric e m pt yi n g i n patie nts wit h dia betic 
gastr o p aresis. Gi ve n t h e k n o w n a nti e metic a n d pr o ki netic effects of d o m p eri d o ne, it is p ossi ble 
t hat patie nts ma y e x perie nce i m pr o v e me nt i n t h eir s y m pt o ms d uri n g t h e c o urse of t his st u d y. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
2 3  
2  
S T U D Y O B J E C TI V E S 
2. 1  
O bjecti ves 
T he o bjecti ves of t his st u d y are t he f oll o wi n g: 
 T o e val uate t he safet y a n d t olera bilit y of m ulti ple d oses of CI N- 1 0 2 i n patie nts wit h dia betic 
gastr o p aresis 
 T o e val uate t he effect of m ulti ple d oses of CI N- 1 0 2 o n gastric e m pt yi n g as meas ure d b y t he 
gastri c e m pt yi n g breat h t est ( G E B T) i n patie nts wit h dia betic gastr o paresis 
 T o c haracteriz e t h e P K of m ulti ple d oses of CI N- 1 0 2 i n patie nts wit h dia betic gastr o paresis  
2. 2  
E x pl or at or y O bjecti ves 
T he e x pl orat or y o bj ecti v es of t his st u d y i ncl u de t he f oll o wi n g: 
 T o assess t he effect of m ulti ple d oses of CI N- 1 0 2 o n n a usea ass oci ate d wit h gastr o paresis 
base d o n t he na us ea s c ore o n t h e A merica n N e ur o gastr oe nt er ol o g y a n d M otilit y S ociet y 
Gastr o paresis Car di nal S y m pt o m I n de x Dail y Di ar y ( A N M S G C SI- D D) 
 T o assess t he effect of m ulti ple d oses of CI N- 1 0 2 o n A N M S G C SI- D D sc ores (t otal a n d 
s u bscales) i n patie nts wit h dia betic gastr o paresis 
 T o assess t he effect of m ulti ple d oses of CI N- 1 0 2 o n a variet y of p atie nt re p orte d o utc o mes 
 T o c haracteriz e e x p os ure-res p o nse relati o ns hi ps of CI N- 1 0 2 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
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3. 3  
D ose Esc al ati o n a n d Re vie w C o m mittee 
A D R C c o nsisti n g of at least t hree me m bers, i ncl u di n g a car di ol o gist, a cli nical p har m ac ol o gist, 
a n d a n i n de pe n de nt cli ni cia n e x perie nce d i n t he treat m e nt of patie nts wit h dia betic gastr o p aresis 
will b e f or me d t o re vie w e mer gi n g P K a n d safet y data i n a bli n de d ma n ner. 
T he D R C will c o n v e ne t o re vi e w s afet y a n d effic ac y d ata t hr o u g h at least D a y 1 4 fr o m 
a p pr o xi matel y 1 5 of t he p atie nts i n eac h c o h ort. P K data fr o m a p pr o xi m atel y 8 patie nts recei vi n g 
CI N- 1 0 2 i n eac h c o h ort will be c o nsi dere d a de q uate f or D R C re vie w. I n t h e e v e nt a patie nt 
disc o nti n ues t he st u d y at least 2 4 h o urs after stea d y-stat e is b elie ve d t o ha ve bee n ac hi e ve d ( base d 
o n a vaila ble data fr o m t he S A D a n d M A D st u dies) f or a reas o n u nrelat e d t o safet y, t he e xisti n g 
data fr o m t hat i n di vi d ual ma y b e s ufficie nt f or decisi o n ma ki n g b y t h e D R C. 
D ose escalati o n will o nl y ta ke place after t he D R C has deter mi ne d t hat is a p pr o priate (e g, a de q uate 
safet y a n d t olera bilit y h a ve bee n de m o nstr ate d a n d P K be h a vi or is w ell e n o u g h c haracterize d t o 
s u p p ort pr ocee di n g t o a hi g h er d os e le vel a n d/ or st u d y of a l o w er d ose le vel or fre q u e nc y is 
mea ni n gf ul base d o n e mer gi n g s afet y d ata). 
U p o n eac h D R C re vie w, t he f oll o wi n g ma y o cc ur: 
 pr ocee d t o t h e n e xt pr ot oc ol-s pecifie d d os e le vel or  
 pr ocee d t o alter nate d osi n g re gi m e n(s) n ot t o e x cee d t he n e xt pr ot oc ol-s pecifie d d ose le vel 
F urt her d etail o n D R C c o n d uct will be descri be d i n t he D R C C h arter.   
3. 3. 1  
Criteria f or T e m p orar y S us p e nsi o n of D osi n g 
D osi n g wit hi n a c o h ort or bet wee n c o h orts will be te m p oraril y s us pe n d e d u ntil a f ull c u m ulati ve 
data re vie w is c o m plete if a n y of t he f oll o wi n g occ ur: 
 A n y st u d y dr u g-relat e d S A E gra de 3 or hi g her b ase d o n C o m m o n T er mi n ol o g y Criteria f or 
A d vers e E v e nts ( C T C A E) Versi o n 5. 0 
 A n y si n gle s u bject w h os e E C G (a vera ge tri pli cate E C Gs as i nter pr ete d b y ce ntral rea d) 
de m o nstrates a heart-rate c orrecte d Q Tc F i nter val ( Q Tc F) > 5 0 0 msec or i n w h o m t h ere is a n 
i ncreas e i n Q Tc F > 6 0 ms ec fr o m b aseli n e (c o nfir me d b y re peat E C G) 
 A n y n e w E C G a b n or malit y dee me d cli nicall y si g nifica nt b y t h e i n vesti gat or 
 A n y st u d y dr u g-relate d car dia c a d verse e ve nt. I n t he e ve nt t hat a patie nt e x perie nces a 
vas o va gal or n ear-s y n c o p al e pis o de, d osi n g wit hi n a c o h ort or s u bse q ue nt c o h ort m a y pr ocee d 
as pla n ne d u nless t he e pis o de is ass o ciate d wit h E C G a b n or malit y or t h e e v e nt is dee me d t o be 
se vere i n i nte nsit y (se verit y) b y t h e I n v esti g at or 
 A st u d y dr u g-relate d a d verse e v e nt fr o m a si n gle S yste m Or ga n Class dee me d t o be of 
m o derate i nte nsit y (se v erit y) i n 4 or m ore p atie nts 
 A n y of t h e f oll o wi n g l a b orat or y a b n or malities t hat are t h o u g ht t o be st u d y dr u g-relat e d or i n 
w hic h a n alter n ati ve e x pla nati o n is n ot reas o na ble: 
o  A L T or A S T > 8 × t h e u p per li mit of n or mal ( U L N), or 
o  A L T or A S T > 5 × U L N a n d persist f or m ore t ha n 2 wee ks, or 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
2 7  
o  A L T or A S T > 3 × U L N i n c o nj u ncti o n wit h ele vate d t otal bilir u bi n > 2 × U L N or 
i nter nati o nal n or malize d rati o > 1. 5, or 
o  A L T or A S T > 3 × U L N wit h a p p eara nce of fati g u e, na usea, v o miti n g, ri g ht u p per q u a dra nt 
pai n or te n d er n ess, fe v er, ras h, a n d/ or e osi n o p hilia ( > 5 %) 
 A n y si n gle patie nt w h o de vel o ps seri o us st u d y dr u g-relat e d electr ol yt e a b n or malities d ue t o 
v o miti n g a n d/ or i n a bilit y t o mai ntai n a de q uate oral h y drati o n t hat i m pacts car diac sta bilit y 
 Ot her c o n diti o ns as dee m e d me dicall y a p pr o priate base d o n t he I n v esti gat or’s j u d ge m e nt 
T he S p o ns or a n d/ or D R C ma y als o s us pe n d d osi n g f or a n y ot her reas o n b ase d o n e mer gi n g d ata. 
S h o ul d d osi n g be te m p oraril y s us pe n d e d, t h e D R C ca n re vie w a n d disc uss all a vaila ble safet y a n d 
P K data fr o m all patie nts partici pati n g i n t he st u d y u p u ntil t h e ti me of t h e e ve nt. T he D R C will 
deci de w h et h er k n o wle d ge of t h e treat me nt assi g n me nt of a n y p atie nt(s) is(are) necessar y t o m a ke 
a n a p pr o priate d ecisi o n a b o ut c o nti n uati o n of t h e st u d y. If s o, a re q u est t o u n bli n d will be m a de 
a n d rel e va nt data will be re vie we d i n a n u n bli n de d m a n ner. All u n bli n di n g Sta n dar d O perati n g 
Pr oce d ures will be f oll o we d a n d d oc u m e nte d as a p pr o priate. 
U p o n c o m pleti o n of t he c u m ulati ve data re vie w ( w het her f ull y bli n de d or partiall y u n bli n de d), t he 
D R C m a y elect t o t er mi nate t he st u d y or t o res u me st u d y c o n d uct. If st u d y c o n d uct is res u me d, t he 
D R C m a y elect t o d o o ne of t he f oll o wi n g: 
 C o nti n ue d osi n g i n t he c urre nt c o h ort wit h t he s a me n u m ber of patie nts ori gi n all y pla n n e d 
 E x pa n d t he c urre nt c o h ort wit h a d diti o nal p atie nts t o o btai n m ore i nf or mati o n at t hat d ose le vel 
 Escalate t o a hi g h er d ose le vel 
 I n crease t he fre q u e nc y of d osi n g at t he c urre nt d ose le vel (if t he pr ot oc ol-s p ecifie d n u m ber of 
s u bjects at t he c urre nt d ose l e vel ha ve alrea d y c o m plete d) 
 De-es calate t o a l o wer d ose le vel 
 Decr ease t h e fre q ue nc y of d osi n g at t he c urre nt d ose le vel 
3. 3. 2  
Criteria t o Cease D os e Escalati o n 
D osi n g wit hi n a c o h ort or bet wee n c o h orts will cease if eit h er of t he f oll o wi n g o cc urs: 
 A n y t w o gra d e 3 or 1 gra de 4 or hi g her st u d y dr u g-relate d S A E base d o n C T C A E Versi o n 5. 0 
 A n y 2 patie nts wit h a n E C G (a vera ge of tri plicate E C Gs as deter mi ne d b y ce ntral rea d) 
de m o nstrati n g Q Tc F > 5 0 0 msec or a c ha n ge i n Q Tc F > 6 0 mse c fr o m baseli n e (c o nfir m e d b y 
re peat E C G wit h ce ntral rea d) 
S h o ul d o ne of t he a b o ve occ ur, c o nsi derati o n ma y still be gi v e n t o c o nti n ue d st u d y of a n alter n ate 
d ose le vel or fre q ue nc y (eit her e x pa nsi o n of a pre vi o usl y st u die d c o h ort or a d diti o n of a l o wer d ose 
le vel).  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
2 8  
4  
S E L E C TI O N A N D WI T H D R A W A L O F P A TI E N T S  
4. 1  
I ncl usi o n Criteri a 
Patie nts w h o meet all of t he f oll o wi n g criteria will be eli gi ble t o p artici pate i n t he st u d y: 
1.  Male a n d fe male patie nts 1 8 t o 7 0 years ol d. 
2.  Has T y p e 1 or T y pe 2 i ns uli n- de pe n de nt dia betes m ellit us, acc or di n g t o t he A merica n Dia b etes 
Ass ociati o n criteria. 
3.  Has a c urre nt dia g n osis of dia betic gastr o p aresis as defi n e d b y t he f oll o wi n g: 
o  Has 
gastr oi ntesti nal ( GI) s y m pt o ms felt t o 
b e 
c o nsiste nt 
wit h 
gastr o p aresis 
(e g, p ost pra n dial n a usea/ v o miti n g, p ost pra n dial f ull ness, earl y satiet y,  bl oati n g, a n d/ or 
e pi gastric/a b d o mi nal pai n) wit hi n t he 6 m o nt hs pri or t o scree ni n g;  
O R 
o  Has d oc u me nte d d ela ye d gastri c e m pt yi n g ( D G E) wit hi n t h e past 3 years as deter mi ne d b y 
G E B T or sci nti gra p h y. Patie nts w h o ha ve D G E d oc u m e nte d t hr o u g h ot her m o dalities 
(e g, S mart Pill, ma n o metr y, etc) or w h o ha ve ha d a n a b n or mal G E B T or sci nti gra p h y 
> 3 years a g o ma y be c o nsi dere d wit h S p o ns or a p pr o val. 
4.  Has a b o d y m ass i n de x ( B MI) b et wee n 1 8 a n d 4 0 k g/ m 2, i ncl usi ve. 
5.  Has gl yc os yl ate d he m o gl o bi n le vel 1 1 %. 
6.  Male patie nts wit h fe male part n ers of c hil d- beari n g p ote ntial m ust a gree t o use 2 m e dicall y 
acce pte d, hi g hl y effecti v e met h o ds of birt h c o ntr ol fr o m Da y 1 t hr o u g h 6 0 da ys f oll o wi n g t he 
fi nal d ose of st u d y dr u g.  
o  Me dicall y acce pte d, hi g hl y effecti ve met h o ds of birt h c o ntr ol f or male patie nts wit h fe male 
part ners of c hil d- beari n g p ote ntial i ncl u de t he f oll o wi n g: late x c o n d o m wit h s per mici de, 
dia p hra g m 
wit h i ntra va gi n al s p er mi ci de, cer vi cal ca p 
wit h s per mici de, i n d welli n g 
i ntra uteri ne de vice ( h or m o nal or n o n h or m o nal), i m pla nte d c o ntrace pti ves, a n d oral 
c o ntrace pti ves.  
7.  Male patie nts m ust a gree t o a bstai n fr o m s per m d o nati o n fr o m Da y 1 t hr o u g h 6 0 da ys 
f oll o wi n g t h e fi n al d ose of st u d y dr u g. 
8.  Fe male patie nts wit h male p art n ers m ust be s ur gi call y sterile ( h ysterect o m y a n d/ or bilateral 
o o p h orect o m y), p ost me n o pa usal f or at least 1 year ( wit h c o nfir m e d f ollicle-sti m ulati n g 
h or m o ne [ F S H] i n p ost m e n o pa usal ra n ge at t h e S cree ni n g Visit), or a gree t o use 2 m e dicall y 
acce pte d, hi g hl y effecti v e met h o ds of birt h c o ntr ol fr o m Da y - 1 4 u ntil 6 0 da ys f oll o wi n g t h e 
fi nal d ose of st u d y dr u g.  
o  Me dicall y acce pte d, hi g hl y effecti ve met h o ds of birt h c o ntr ol f or fe male pati e nts wit h male 
part ners i n cl u de t he f oll o wi n g: late x c o n d o m wit h s per mici de, dia p hra g m wit h i ntra va gi nal 
s per mici d e, cer vical ca p wit h s per mici de, a n d n o n h or m o nal i n d welli n g i ntra uteri ne de vice. 
9.  Has a ne gati ve breat h al c o h ol a n d uri ne dr u g scree n (i ncl u di n g tetra h y dr oca n na bi n ol) at t he 
Scree ni n g Visit a n d at t h e ti me of ra n d o mizati o n.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
2 9  
 
 
1 1.  Is a ble t o u n derst a n d a n d willi n g t o c o m pl y wit h all st u d y visits, pr oce d ures, restricti o ns, 
disc o nti n uati o n of m e dicati o ns, i ncl u di n g t h ose t o treat gastr o paresis (as s pecifi e d i n t he 
pr ot oc ol), a n d pr o vi de writte n i nf or me d c o nse nt acc or di n g t o i nstit uti o nal a n d re g ulat or y 
g ui deli nes. 
4. 2  
E xcl usi o n Criteri a 
Patie nts w h o meet a n y of t he f oll o wi n g criteria will be e xcl u de d fr o m p artici pati o n i n t h e st u d y: 
1.  Has a hist or y of, or c urre nt, cli nicall y si g nifica nt arr h yt h mias as j u d ge d b y t h e I n v esti gat or, 
i ncl u di n g v e ntric ular tac h ycar di a, ve ntric ul ar fi brillati o n, a n d T orsa d es d e p oi ntes. Patie nts 
wit h mi n or f or ms of ect o p y (e g, pre mat ure atrial c o ntracti o ns) are n ot n ecessaril y e x cl u de d, 
per I n vesti gat or discreti o n. 
2.  Has cli nicall y si g nifi ca nt bra d ycar dia wit h a resti n g heart rate u n der 5 0 beats p er mi n ute, si n us 
n o de d ysf u ncti o n, or heart bl o c k. 
3.  Has pr ol o n ge d heart rate-c orrecte d 
Q T i nter val usi n g Fri deri cia’s f or m ula ( Q T c F) 
( Q Tc F > 4 5 0 ms ec f or males or Q Tc F > 4 7 0 msec f or fe mal es) bas e d o n t he a vera ge of tri plicate 
E C Gs. 
4.  Has a pers o n al or fa mil y hist or y of l o n g Q T s y n dr o me, T orsa des de p oi ntes, or ot h er c o m ple x 
ve ntric ul ar arr h yt h mias or fa mil y hist or y of s u d d e n deat h. 
5.  Has e vi d e nce ( base d o n scree ni n g or b aseli ne assess me nts) or hist or y of cli nicall y si g nifi ca nt 
i m m u n ol o gic, he mat ol o gic, re nal, e n d o cri ne, p ul m o nar y, 
GI, c ar di o vasc ular, h e patic, 
ps yc hiatric, ne ur ol o gi c, or aller gic dis ease (i ncl u di n g dr u g aller gies); s ur gic al c o n diti o ns; 
ca ncer ( wit h t he e xce pti o n of basal or s q ua m o us cell carci n o ma of t he s ki n a n d ca ncer t hat 
res ol v e d or h as bee n i n re missi o n f or > 5 years pri or t o t he Scree ni n g Visit); or a n y c o n diti o n 
t hat, i n t he I n vesti gat or’s o pi ni o n, 
mi g ht si g nifica ntl y i nterfere 
wit h t h e a bs or pti o n, 
distri b uti o n, meta b olis m, or e x creti o n of t he st u d y dr u g.  
N ote: C h olec yst ect o m y a n d a p pe n dect o m y are all o w e d. 
6.  Has a hist or y of pr ol acti n-releasi n g pit uitar y t u m or (ie, pr olacti n o ma). 
7.  Has ele vate d ser u m pr ol acti n.  
N ote: Patie nts w h o are o n d o m peri d o ne wit h a n ele vate d pr ola cti n at t h e ti m e of scree ni n g m a y 
be c o nsi d ere d f or t his st u d y. 
8.  Has k n o w n or s us pecte d h y p o g o na dis m, c urre nt cli nicall y si g nifica nt me nstr ual a b n or maliti es 
(e g, oli g o m e n orr hea or a me n orr hea), g y n ec o masti a, galact orr hea, or ot her cli nical feat ures t h at 
i n t h e I n v esti g at or’s o pi ni o n ma y be c o nsiste nt wit h h y per pr olacti ne mia. 
9.  Has p yl oric i njecti o n of b ot uli n u m t o xi n wit hi n 6 m o nt hs of scree ni n g a n d/ or d uri n g t h e c o urse 
of t he st u d y. 
1 0.  Has 
bilir u bi n, al kali ne 
p h os p hatase, as p artat e a mi n otra nsferase ( A S T), 
or ala ni ne 
a mi n otra nsfer ase ( A L T) le vels greater t ha n 2 × t h e u p per li mit of n or mal or has a C hil d- P u g h 
classificati o n gra de of B or C. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
3 0  
1 1.  Has a ser u m creati ni ne le vel greater t ha n 1. 5 × t he u p per li mit of n or mal or has a n esti m ate d 
gl o mer ular filtrati o n rate (e G F R) < 3 0 m L/ mi n/ 1. 7 3 m 2 usi n g t he C hr o nic Ki d ne y Disease 
E pi de mi ol o g y C olla b orati o n ( C K D- E PI) e q u ati o n at scree ni n g. 
1 2.  Has a he m o gl o bi n le vel < 1 0 g/ d L at scree ni n g.  
1 3.  Has t h yr oi d-sti m ulati n g h or m o ne ( T S H) le vels t hat are a b n or m al at s cree ni n g, as j u d ge d b y 
t he I n v esti gat or. 
1 4.  Has i na bilit y t o perf or m a breat h test. 
1 5.  Has k n o w n aller g y t o e g gs or s pir uli n a. 
1 6.  Use of i n vesti gati o nal, prescri pti o n, or o ver-t he-c o u nter me dicati o ns as f oll o ws: 
 
  
  
 
 
  
  
  
  
 
 
o  Acti vel y p arti ci pati n g i n a n e x peri me ntal t hera p y st u d y; recei ve d e x peri m e ntal t hera p y 
wit h a s mall m olec ule wit hi n 3 0 da ys of ra n d o miz ati o n or 5 half-li ves ( w hic he ver is 
l o n ger); or recei ve d e x peri m e ntal t hera p y wit h a lar ge m olec ule wit hi n 9 0 da ys of 
ra n d o mizati o n or 5 half-li v es, ( w hic he ver is l o n ger). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 7.  Hist or y of alc o h olis m or dr u g a b use wit hi n 2 years pri or t o d osi n g as d efi ne d b y t h e Dia g n osti c 
a n d Statisti cal Ma n ual of Me ntal Dis or ders, 4t h E diti o n. 
1 8.  T y pic al c o ns u m pti o n of 1 4 alc o h oli c dri n ks wee kl y. 
1 9.  Hist or y or e vi de nce of illicit dr u g use. 
2 0.  P ositi ve f or h u ma n i m m u n o deficie nc y vir us ( HI V) a nti b o d y, h e patitis C vir us ( H C V) a nti b o d y, 
or he patitis B s urface a nti ge n ( H Bs A g) at t h e Scree ni n g Visit. 
2 1.  D o nate d bl o o d or bl o o d pr o d ucts wit hi n 3 0 da ys pri or t o d osi n g. 
2 2.  C urre ntl y u n der g oi n g treat me nt wit h wei g ht l oss m e dicati o n or pri or w ei g ht l oss s ur ger y 
(e g, gastric b y p ass s ur ger y). 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
3 1  
2 3.  Pre g n a nt, breastfee di n g, or pla n ni n g t o bec o me pre g n a nt d uri n g t he c o urse of st u d y. 
2 4.  I n a bilit y t o s wall o w m e dicati o n. 
2 5.  C urre ntl y recei vi n g p are nteral fee di n g or prese n ce of a n as o gastric or ot her e nteral t u be 
(e g, perc uta ne o us e n d osc o pic gastr ost o m y [ P E G] t u be) f or fee di n g or dec o m pressi o n. 
2 6.  K n o w n or s us pect e d gastric o utlet o bstr ucti o n (e g, pe ptic stri ct ure) or ot h er GI mec ha nic al 
o bstr ucti o n as d oc u me nt e d b y u p per GI tr act e n d os c o p y or u p p er GI ra di o gra p hic series i n t he 
past 3 years. 
2 7.  K n o w n hist or y or c urre nt dia g n osis of i ntesti n al mala bs or pti o n or pa ncreatic e x ocri ne disease. 
2 8.  Hist or y of gastri c s ur ger y s uc h as f u n d o plicati o n, gastrect o m y, va g ot o m y, p yl or o plast y, or 
bariatric pr o ce d ure.  
N ote: Patie nts w h o ha ve a gastric p ace ma k er i n place m a y b e c o nsi d ere d f or t he st u d y if t he 
pace ma k er ca n be t ur n e d off f or at least 1 4 da ys pri or t o baseli n e G E B T a n d t hr o u g h o ut t he 
re mai n der of t h e st u d y. 
N ote: 
A hist or y of dia g n ostic e n d osc o p y is n ot e xcl usi o nar y. 
C h olec yst ect o m y a n d 
a p pe n dect o m y are all o we d. 
2 9.  Hist or y or pres e nce of a n y me dical c o n diti o n or ps yc hi atric disease, w hic h, i n t he o pi ni o n of 
t he I n v esti gat or, c o ul d i nterfere wit h t he c o n d uct of t he st u d y or w o ul d p ut t he patie nt at 
u nacce pta ble ris k. 
3 0.  Pri or lac k of res p o nse t o d o m peri d o ne or k n o w n h y p erse nsiti vit y or i nt olera n ce t o 
d o m peri d o ne or a n y of t he e xci pie nts i n t he CI N- 1 0 2 f or m ulati o n. 
3 1.  J u d ge d b y t h e I n vesti gat or, after re vie wi n g 
me dical a n d ps yc hiatri c hist or y, p h ysical 
e x a mi nati o n, a n d la b orat or y e v al uati o n, t o be u ns uita ble f or a n y ot h er reas o n t hat ma y eit her 
place t he p atie nt at i ncrease d ris k d uri n g p arti ci pati o n or i nterfere wit h t he i nter pretati o n of t he 
st u d y o utc o m es. 
4. 3  
R a n d o miz ati o n Criteri a 
I n a d diti o n t o t he ge neral criteria liste d i n Secti o ns 4. 1  a n d 4. 2 , i n or der t o be ra n d o mize d i nt o t he 
st u d y, patie nts m ust als o meet t h e f oll o wi n g criteria at t h e ti me of ra n d o mizati o n: 
 C o nti n ues t o satisf y all i ncl usi o n/e x cl usi o n criteria. 
 Has bee n off all m otilit y a ge nts a n d a ntie metics f or at least 1 4 d a ys a n d is willi n g t o re mai n 
off s uc h me dicati o ns (e xce pt f or pr ot oc ol-s pecifie d a ntie meti c resc ue me di cati o n) d uri n g t he 
c o urse of t he st u d y. 
 De m o nstrates a c o nfir me d dia g n osis of dia b etic gastr o paresis as defi ne d b y t h e f oll o wi n g: 
o  C urre nt u p per GI s y m pt o ms (e g, n a usea/ v o miti n g, p ost pra n di al f ull ness, earl y satiet y, 
bl oati n g, a n d/ or e pi gastric/ a b d o mi nal pai n). 
o  D oc u m e nte d D G E wit hi n t h e 5 da ys pri or t o first d ose of st u d y dr u g b ase d o n G E B T usi n g 
1 3C-s pir uli n a plate nsis de m o nstrati n g T ½ > 9 1 mi n utes ( 9 0 t h perce ntile of n or mal) a n d 
< 2 0 0 mi n utes. 2 0  
 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
3 3  
5  
S T U D Y T R E A T M E N T S 
5. 1  
Tre at me nt Gr o u ps 
T his st u d y is pla n ne d t o i ncl u de 4 treat m e nt gr o u ps wit h 1 5 patie nts eac h.  
At ra n d o mizati o n, patie nts w h o meet all eli gi bilit y criteria ( base d o n i ncl usi o n/e x cl usi o n a n d 
ra n d o mizati o n crit eria) will b e ra n d o mize d t o eit her CI N- 1 0 2 BI D or pl ace b o BI D i n a 3: 1 rati o. 
T he st u d y will be gi n b y ra n d o mizi n g p atie nts i n C o h ort 1 t o eit her CI N- 1 0 2  
 BI D or 
place b o BI D s uc h t h at 1 5 s u bjects recei ve CI N- 1 0 2 a n d 5 s u bjects recei v e place b o. A n 
i n de pe n de nt D R C will re vie w e mer gi n g safet y, P K, a n d/ or efficac y d ata t hr o u g h o ut t he st u d y t o 
deter mi n e if it is safe a n d a p pr o priate t o c o nti n ue t he st u d y wit h t he c urre ntl y pla n n e d d ose le v els 
f or C o h orts 2 a n d 3 or if f urt her refi ne me nt of t h e pr o p ose d d ose le vels is warra nt e d. C urre ntl y 
pla n ne d d ose le vels f or C o h orts 2 a n d 3 are  
 BI D a n d  
 BI D, res pecti vel y, wit h 1 5 
patie nts recei vi n g st u d y dr u g a n d 5 patie nts recei vi n g place b o i n eac h c o h ort. H o we ver, t hes e 
pla n ne d d ose le v els ma y be m o difie d a n d/ or a d diti o nal c o h orts ma y be a d d e d base d o n e mer gi n g 
i nf or mati o n fr o m t he c urre nt st u d y as well as ot h er o n g oi n g st u dies. T he hi g hest d ose will n ot 
e x cee d  
 BI D a n d n o m ore t h a n 4 0 a d diti o nal pati e nts will be a d de d wit h o ut a pr ot oc ol 
a me n d me nt. T he D R C will als o deter mi ne h o w t o a d va nce t h e c o h orts. F urt h er details re gar di n g 
t he r ole, res p o nsi bilities, a n d pr oce d ures of t h e D R C will be pr o vi de d i n t he D R C C harter. 
T he d urati o n of t he d o u ble- bli n d treat m e nt peri o d will be 1 4 da ys ( ± 2 da ys) of st u d y dr u g 
a d mi nistrati o n.  
5. 2  
R ati o n ale f or D osi n g 
T w o cli nical st u dies of CI N- 1 0 2 i n healt h y s u bjects ha ve c o m me nce d t o date: a S A D st u d y (st u d y 
CI N- 1 0 2- 1 1 1) a n d a M A D st u d y (st u d y CI N- 1 0 2- 1 1 2). I n
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
 
  
 
 
 
 
 
 
 
 
 
 

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Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
3 4  
5. 3  
R a n d o miz ati o n a n d Bli n di n g 
Patie nts w h o ha ve c o m plete d t he Scree ni n g Visit a n d meet all of t he i n cl usi o n, n o ne of t h e 
e x cl usi o n crit eria, a n d all of t h e a d diti o nal criteria base d o n ra n d o mizati o n pr oce d ures, i n cl u di n g 
safet y la b orat or y t ests (s ee Se cti o n 6. 5), will be ra n d o mize d i nt o t h e st u d y. Ra n d o mizati o n will 
occ ur o n Da y 1. Ra n d o mizati o n assi g n me nts will b e pr o vi de d b y 
 
 (I R T). F oll o wi n g ra n d o mizati o n, st u d y dr u g will be dis pe nse d i n a d o u ble- bli n d 
ma n ner o n Da y 1. T h e S p o ns or a n d all cli nical p ers o n nel will b e bli n de d t o t he treat me nt gr o u p 
f or eac h patie nt. Patie nts will als o be bli n de d t o t he treat me nt t he y recei ve. 
Bi oa nal ytical staff i n v ol ve d i n a nal ysis of P K sa m ples will be u n bli n de d t o treat m e nt eit h er via 
recei pt of t h e ra n d o mizati o n c o de t o all o w f or a n al ysis of sa m ples fr o m patie nts recei vi n g CI N- 1 0 2 
o nl y (a n d p ossi bl y li mite d a nal ysis of sa m ples fr o m patie nts recei vi n g plac e b o), or b y t h e nat ure 
of t he res ults of s a m ple a nal ysis. T h e P K d ata will be d e-i de ntifie d b ef ore bei n g pr o vi de d t o a n y 
ot her i n di vi d uals, i ncl u di n g t h ose i n v ol ve d i n calc ulati n g P K para meters a n d ass ociate d d escri pti ve 
statisti cs, p erf or mi n g a n y m o delli n g or si m ulati o ns, a n d/ or pl otti n g P K d ata, i n or der t o mai ntai n 
bli n di n g. 
5. 4  
Bre a ki n g t he Bli n d 
Bli n di n g is n ot t o be br o ke n d uri n g t he st u d y u nl ess c o nsi dere d n ecessar y b y t he I n vesti gat or f or 
e mer ge nc y sit uati o ns f or reas o ns of patie nt safet y. U n bli n di n g at t he site f or a n y ot her reas o n will 
be c o nsi dere d a pr ot o c ol de viati o n. T he I n vesti gat or s h o ul d c o ntact t he M e dical M o nit or b ef ore 
brea ki n g t he bli n d, if ti me per mits. W h e n t he bli n d is br o ke n, t he reas o n m ust be f ull y d oc u me nte d. 
T he I n vesti gat or will be i nf or me d of tr eat m e nt assi g n me nt via  
I R T. 
5. 5  
Dr u g S u p plies 
5. 5. 1  
F or m ulati o n a n d Pac k a gi n g 
 
 
 
  
 
 
 
 
5. 5. 2  
St u d y Dr u g Pre parati o n a n d Dis pe nsi n g 
CI N- 1 0 2 a n d matc hi n g place b o ca ps ules will be pr o vi de d t o t he site b y t h e S p o ns or or desi g n ee. 
5. 5. 3  
St u d y Dr u g A d mi nistrati o n 
All patie nts will ta ke a d ose of bli n de d st u d y dr u g ( CI N- 1 0 2 or place b o ca ps ules) orall y at 
A M  
 a n d  
P M 
 
 Patie nts will fast f or a 
mi ni m u m of 8 h o urs bef ore a n d 4 h o urs aft er t he m or ni n g d ose o n Da y 1 a n d a mi ni m u m of 8 
h o urs bef ore t he m or ni n g d ose a n d 4 h o urs f oll o wi n g t he c o m pleti o n of t he G E B T meal o n Da y 

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C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
3 5  
1 4 [ ± 2 da ys]. 
 D uri n g 
c o nfi ne me nt a n d o ut patie nt visits, st u d y dr u g will be a d mi nistere d at t h e sit e b y site staff. Patie nts 
will b e pr o vi de d st u d y dr u g f or self-a d mi nistrati o n f or d oses n ot a d mi nistere d  at t he site. 
5. 5. 4  
Treat m e nt C o m plia nce 
St u d y dr u g will b e a d mi nistere d at t h e sit e b y site staff d uri n g p atie nt c o nfi ne me nt a n d at all 
o ut patie nt visits. A ha n d a n d m o ut h c hec k will be perf or me d b y site staff t o e ns ure st u d y dr u g 
c o m plia nce. D osi n g c o m pli a nce will be rec or de d b y t he I n v esti gat or or desi g nee at t he site. T he 
date a n d ti me of st u d y dr u g a d mi nistrati o n will be rec or de d. 
F or all pr ot oc ol-s p ecifie d d oses w h e n t he patie nt is n ot at t h e site, patie nts will self-a d mi nister 
st u d y dr u g a n d will rec or d t he d ate a n d ti me of st u d y dr u g a d mi nistrati o n. C o m pli a nce t o st u d y 
dr u g will als o b e assess e d b y cli nical sit e pers o n nel via t a blet c o u nts of st u d y dr u g a n d b y 
q uesti o ni n g t he patie nt, if n ecessar y, u p o n ret ur n t o t he site o n Da ys 3 [ ± 1 d a y], 7 [ ± 1 da y], 1 0 [ ± 1 
da y], a n d 1 4 [ ± 2 da ys]. A patie nt w h o is n ot c o m plia nt (c o m plia nce bei n g d efi ne d as ha vi n g t a ke n 
7 5 % of st u d y dr u g) will be c o u nsele d at eac h visit o n t he i m p orta nce of ta ki n g st u d y dr u g as 
i nstr ucte d. 
If a patie nt wit h dra ws fr o m t he st u d y or d o es n ot c o m pl y wit h t h e st u d y pr ot oc ol pr oce d ures, t he 
patie nt ca n cease partici pati o n i n t he st u d y b ut will still be c o nsi d ere d e val ua ble f or safet y 
p ur p oses. If a patie nt wit h dra ws fr o m t he st u d y or d oes n ot c o m pl y wit h t he pr ot o c ol after recei vi n g 
st u d y dr u g b ut b ef ore D a y 1 4 pr oce d ures ha v e b ee n perf or me d, t h e y will be re q u este d t o u n d er g o 
t he Earl y Ter mi n ati o n pr oce d ures. 
5. 5. 5  
St ora ge a n d A cc o u nta bilit y 
Rec or ds will be mai ntai ne d i n dicati n g t he recei pt a n d dis pe nsati o n of all st u d y dr u g s u p plies. At 
t he c o ncl usi o n of t h e st u d y, a n y u n use d st u d y dr u g will b e ret ur ne d t o t he S p o ns or or desi g n ee f or 
fi nal dr u g acc o u nt a bilit y a n d destr ucti o n. A certifi cate of d estr u cti o n will be pr o vi de d. If n o st u d y 
dr u g re mai ns, t his will be i n dicate d i n t he Dr u g A cc o u nta bilit y L o g. 
 
 
 
5. 6  
Pri or a n d C o nc o mit a nt Me dic ati o ns a n d/ or Pr o ce d u res 
5. 6. 1  
E x cl u de d Me dicati o ns, F o o ds, a n d/ or Pr oce d ures 
Use of t h e f oll o wi n g i n vesti gati o nal, prescri pti o n, or o ver-t he-c o u nt er me di cati o ns is n ot per mitte d 
d uri n g t he st u d y: 
 
 
 E x peri m e ntal t hera p y wit h a s mall m olec ule wit hi n 3 0 da ys pri or t o ra n d o miz ati o n or 
5 half-li v es ( w hic h e ver is l o n ger); or e x peri me ntal t hera p y wit h a l ar ge m olec ule wit hi n 
9 0 da ys pri or t o ra n d o mi zati o n or 5 half-li ves ( w hic he ver is l o n ger). 
 
 
 
 

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Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
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 P yl oric i njecti o n of b ot uli n u m t o xi n wit hi n 6 m o nt hs of s cree ni n g a n d d uri n g t h e c o urse of t h e 
st u d y. 
 Wei g ht l oss me dicati o n or pri or wei g ht l oss s ur ger y (e g, gastric b y p ass s ur ger y). 
 Pare nteral fee di n g or pres e nce of a nas o gastric or ot her e nteral t u be (e g, P E G t u be) f or fee di n g 
or dec o m pressi o n. 
5. 6. 2  
Restricte d Me dicati o ns a n d/ or Pr oce d ures 
Resc ue Me dicati o ns 
  
 
 Patie nts w h o re q uire f urt her treat me nt wit h pr o hi bite d me dicati o ns ma y be 
disc o nti n ue d fr o m st u d y treat m e nt (at discreti o n of t h e I n vesti gat ors a n d i n c o ns ult wit h t he 
S p o ns or’s M e dical M o nit or) a n d u n der g o f oll o w- u p st u d y pr oce d ures. 
5. 6. 3  
All o we d Me dicati o ns a n d/ or Pr oce d ures 
Ot her m e dicati o ns t hat are n ot e x pli citl y a n d pre vi o usl y e x cl u de d are per mitte d (e g, resc ue 
me dicati o ns i n acc or da nce wit h Secti o n 5. 6. 2) after a p pr o val fr o m t he I n vesti gat or. 
5. 6. 4  
D oc u m e ntati o n of Pri or a n d C o nc o mita nt Me dicati o n Use 
A n y me di cati o ns a d mi nistere d 2 8 da ys pri or t o t he first d ose of st u d y dr u g a n d/ or d uri n g t he st u d y 
peri o d m ust be rec or de d. 

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Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
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6  
S T U D Y P R O C E D U R E S 
6. 1  
I nf or me d C o ns e nt 
Writte n i nf or me d c o nse nt f or t h e st u d y will be o btai ne d fr o m all patie nts bef ore a n y st u d y 
pr oce d ures are perf or me d. See Secti o n 1 1. 3  f or d etails o n i nf or me d c o nse nt. 
6. 2  
P h a r m a c o ge n o mic Assess me nts 
A si n gle, o pti o nal P G x bl o o d sa m ple m a y be c ollecte d at a n y ti me d uri n g t he patie nt’s parti ci pati o n 
i n t h e st u d y. I n or der t o ha ve a P G x s a m ple c ollecte d, patie nts m ust pr o vi d e writt e n i nf or me d 
c o nse nt t o partici pate, w hic h is i ncl u de d i n t he mai n i nf or me d c o nse nt f or m (I C F). T he p atie nt 
ma y wit h dra w c o nse nt t o parti ci pate i n t h e P G x assess me nt at a n y ti me d uri n g t he st u d y wit h o ut 
wit h dra wi n g c o nse nt t o partici pate i n t he st u d y. See Secti o n 7. 5  f or a d diti o nal d etails o n t he P G x 
assess me nts. 
6. 3  
Scree ni n g Visit ( D a ys - 2 8 t o - 8) 
Scree ni n g pr o ce d ures, i n cl u di n g vital si g n assess me nts, ma y be re peate d n o m ore t ha n 2 ti m es f or 
eli gi bilit y p ur p oses. Pati e nts w h o are scree ne d b ut faile d t o meet i ncl usi o n/e x cl usi o n criteria 
( des pit e p ote ntiall y ha vi n g u n der g o n e re peate d scree ni n g ass ess m e nts, if rele va nt) ma y b e 
c o nsi dere d f or rescree ni n g wit h pri or writt e n s p o ns or a p pr o val. 
F or all patie nts, t he Scree ni n g Visit will occ ur u p t o 2 8 da ys pri or t o ra n d o miz ati o n ( bet wee n 
Da ys - 2 8 a n d - 8). T he f oll o wi n g pr o ce d ures will be perf or me d at t h e S cree ni n g Visit: 
 O btai n i nf or me d c o nse nt. 
 Assess eli gi bilit y b ase d o n i ncl usi o n/e x cl usi o n criteria.  
 Rec or d de m o gra p hics a n d me dical/s ur gical hist or y.  
 Rec or d pri or me di cati o ns.  
 Perf or m c o m plete p h ysi cal e xa mi nati o n ( ge neral a p peara n ce, s ki n, hea d, e yes, ears, m o ut h, 
or o p har y n x, nec k, heart, l u n gs, a b d o me n, e xtre mities, a n d ne ur o m usc ular s yste m).  
 Meas ure h ei g ht a n d wei g ht a n d calc ulate B MI. 
 Perf or m breat h alc o h ol test. 
 C oll ect uri ne sa m ples f or t he f oll o wi n g: 
o  Uri nal ysis.  
o  Uri ne dr u g scree n.  
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 Perf or m 1 2-lea d E C G (i n tri plicate a p pr o xi m atel y 1 mi n ute a part after t he patie nt has bee n 
resti n g i n t he s u pi ne p ositi o n f or at least 1 0 mi n utes).  
N ote: Scree ni n g 1 2-lea d E C Gs will be pri nte d a n d will be i nter prete d as s o o n as p ossi ble b y 
t he I n v esti gat or or S u bi n vesti gat or.  

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Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
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 C oll ect bl o o d sa m ples f or t he f oll o wi n g: 
o  C he mistr y, he mat ol o g y, c oa g ulati o n, a n d pr ola cti n.  
o  F S H ( o nl y f or fe males w h o h a ve bee n p ost m e n o pa usal f or at least 1 year a n d are n ot 
s ur gicall y sterile). 
o  T S H. 
o  Ser u m pre g na nc y test ( o nl y f or fe males w h o are n ot s ur gicall y sterile or p ost me n o pa usal 
f or at least 1 year [ wit h c o nfir me d F S H i n p ost m e n o pa usal ra n ge]). 
o  HI V, H Bs A g, a n d H C V s cree n.  
 
 
 
 
6. 4  
B aseli n e G astric E m pt yi n g Bre at h T est Visit ( D a ys - 7 t o - 2) 
Baseli ne G E B T will be p erf or me d b et wee n D a ys - 7 a n d - 2 after a mi ni m u m 1 4- da y w as h o ut fr o m 
m otilit y a ge nts. 
T he f oll o wi n g pr oce d ures will be perf or me d at t he Baseli n e G E B T Visit ( Da ys - 7 t o - 2): 
 Assess fasti n g bl o o d gl uc ose bef ore gastric e m pt yi n g assess me nts t o e ns ure a bl o o d gl u c ose of 
2 7 5 m g/ d L. 
 
 
 O btai n breat h sa m ples f or G E B T t wi ce pri or t o c o ns u m pti o n of a st a n dar dize d, 
1 3C-e nric he d 
meal per t h e st u d y ma n ual a n d t he n at 4 5, 9 0, 1 2 0, 1 5 0, 1 8 0, a n d 2 4 0 mi n utes after meal 
c o ns u m pti o n after a n 8- h o ur fast. 
 Rec or d pri or me di cati o ns. 
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 C oll ect a bl o o d sa m ple f or a ser u m pre g na n c y test. 
 
  
6. 5  
R a n d o miz ati o n ( D a y - 1 or D a y 1) 
Eli gi ble patie nts will be ra n d o mi ze d t o recei ve CI N- 1 0 2 or place b o. Ra n d o mizati o n will occ ur o n 
t he m or ni n g of Da y 1, alt h o u g h ra n d o mizati o n pr oce d ures ma y als o be perf or me d at a se parate 
o ut patie nt visit 1 da y pri or t o ta ki n g t h e m or ni n g d ose of st u d y dr u g ( D a y - 1) t o all o w a de q uate 
t ur nar o u n d ti me f or test res ults if necess ar y. T h e safet y l a b orat or y t ests (ie, c he mistr y, h e mat ol o g y, 
c oa g ulati o n, a n d uri nal ysis) fr o m Da y - 1 or D a y 1 will be pr ocesse d at l ocal la b orat ories f or 
verif yi n g patie nt eli gi bilit y.  Bl o o d a n d uri n e sa m ples f or cli nical safet y la b orat or y t ests will als o 
be se nt t o t he ce ntral la b orat or y f or a nal ysis. A P O C uri ne pre g n a nc y test a n d uri ne dr u g scree n 
will b e use d t o ass ess eli gi bilit y f or t h e p ur p ose of ra n d o miz ati o n. Uri ne a n d ser u m c oll ecte d as 

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C o nfi d e ntial & Pr o prietar y 
 
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part of ra n d o mizati o n pr oce d ures will als o be se nt t o t he ce ntr al la b f or c o nfir mat or y dr u g a n d 
pre g na nc y t esti n g, res pecti vel y. Eli gi bilit y m a y be base d o n Scree ni n g pr ol acti n test res ults. 
T he f oll o wi n g pr oce d ures will be perf or me d at t he ti me of ra n d o mi zati o n ( Da y - 1 or D a y 1): 
 Assess eli gi bilit y b ase d o n i ncl usi o n/e x cl usi o n a n d ra n d o mizati o n criteria.  
 Rec or d me dical/s ur gi cal hist or y.  
 Rec or d pri or me di cati o ns.  
 Perf or m li mite d p h ysical e x a mi nati o n ( mi ni m u m of ge neral a p peara nc e, s ki n, heart, l u n gs, a n d 
a b d o me n).  
 Meas ure wei g ht a n d calc ulate B MI usi n g hei g ht fr o m t he Scree ni n g Visit. 
 Perf or m breat h alc o h ol test. 
 C oll ect uri ne sa m ples f or t he f oll o wi n g: 
o  Uri nal ysis 
o  Uri ne dr u g scree n  
o  P oi nt- of-care ( P O C) uri n e dr u g scree n.  
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 Perf or m 1 2-lea d E C G (i n tri plicate a p pr o xi m atel y 1 mi n ute a part after t he patie nt has bee n 
resti n g i n t he s u pi ne p ositi o n f or at least 1 0 mi n utes).  
N ote: 1 2-lea d E C Gs will be pri nte d a n d will be i nter prete d as s o o n as p ossi ble b y t he 
I n v esti gat or. A di gital rec or di n g of eac h E C G will be s u b mitte d t o a ce ntral re vie wer. 
 C oll ect bl o o d sa m ples f or t he f oll o wi n g:  
o  C he mistr y, he mat ol o g y, c oa g ulati o n, a n d pr ola cti n.  
N ote: Pr olacti n res ults are n ot re q uire d pre-ra n d o mi zati o n. 
 C oll ect P O C pre g na n c y test res ults ( o nl y f or fe males w h o are n ot s ur gicall y sterile or 
p ost me n o pa usal f or at least 1 year [ wit h c o nfir me d F S H i n p ost me n o pa usal ra n ge at t he 
Scree ni n g Visit]). 
 
 
 
 
 

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Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
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6. 6  
Tre at me nt Peri o d – D a ys 1 t o 1 5 
F or o ut p atie nt visits, patie nts will re p ort t o t he cli nic bef ore t a ki n g t heir m or ni n g d ose of st u d y 
dr u g. 
6. 6. 1  
Da y 1 
T he f oll o wi n g pr oce d ures will be perf or me d o n D a y 1:  
 Rec or d c o n c o mita nt me dicati o ns ( pri or t o eac h d ose) a n d a d v erse e ve nts.  
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 Perf or m 1 2-l ea d E C G 
 
  
N ote: 1 2-lea d E C Gs s h o ul d be perf or me d i n tri plicate a p pr o xi matel y 1 mi n ute a part aft er t he 
patie nt has bee n r esti n g i n t he s u pi ne p ositi o n f or at least 1 0 mi n utes. E C Gs perf or me d after 
t he m or ni n g d ose s h o ul d be c o m plete d ± 1 5 mi n utes fr o m t he s pecifie d ti me p oi nts of  
 
  
N ote: 1 2-lea d E C Gs will be pri nte d a n d will be i nter prete d as s o o n as p ossi ble b y t he 
I n v esti gat or. A di gital rec or di n g of eac h E C G will be s u b mitte d t o a ce ntral re vie wer. 
N ote: i n t he e v e nt t he s p o ns or pr o vi d es writt e n a p pr o val t o wai v e o ne or m ore P K sa m ples a n d 
t he s u bject is disc har ge d pri or t o c o m pleti o n of t he 1 2- h o ur P K pr ofile, a n E C G m ust be 
c ollecte d w h e n t he fi nal P K sa m ple is o btai ne d. 
 If t h e patie nt c o nti n ues t o meet all eli gi bilit y criteria, t he patie nt will b e ra n d o mize d a n d 
treat me nt assi g ne d via I R T.  
 A d mi nister st u d y dr u g (all patie nts will ta ke a d ose of bli n de d st u d y dr u g [ CI N- 1 0 2 or place b o 
ca ps ules] orall y at  
A M  
 a n d  
P M  
 
 
 
 
 T h e e ve ni n g d os e will be self-a d mi nistere d b y t he 
s u bject. 
 Dis pe nse t he necessar y a m o u nt of st u d y dr u g f or s elf-a d mi nistrati o n f or D a y 2 (a n d Da y 3 
[ ± 1 da y] as n ee de d). 
 C oll ect bl o o d sa m ples f or t he f oll o wi n g: 
o  Pr olacti n. Sa m ple c ollecte d pre d ose.  
o  P K a nal ysis 
 
 
 
 
 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
4 1  
 
 
 
 
 
6. 6. 2  
Da y 2 
T he f oll o wi n g pr oce d ures will be perf or me d b y t h e patie nt o n Da y 2: 
 Rec or d c o n c o mita nt me dicati o ns a n d a d verse e v e nts. 
 
 
 Self-a d mi nister st u d y dr u g (all patie nts will ta ke a d ose of bli n de d st u d y dr u g [ CI N- 1 0 2 or 
place b o ca ps ules] orall y at  
A M  
 a n d  
P M 
 
 
 
 
6. 6. 3  
Da y 3 ( ± 1 Da y) 
T he f oll o wi n g pr oce d ures will be perf or me d as a n o ut p atie nt visit o n Da y 3 ( ± 1 da y): 
 Rec or d c o n c o mita nt me dicati o ns a n d a d verse e v e nts.  
 C oll ect uri ne sa m ples f or uri nal ysis. 
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 Perf or m 1 2-lea d E C G (i n tri plicate a p pr o xi m atel y 1 mi n ute a part after t he patie nt has bee n 
resti n g i n t he s u pi ne p ositi o n f or at least 1 0 mi n utes).  
N ote: 1 2-lea d E C Gs will be pri nte d a n d will be i nter prete d as s o o n as p ossi ble b y t he 
I n v esti gat or. A di gital rec or di n g of eac h E C G will be s u b mitte d t o a ce ntral re vie wer. 
 A d mi nister st u d y dr u g (all patie nts will ta ke a d ose of bli n de d st u d y dr u g [ CI N- 1 0 2 or place b o 
ca ps ules] orall y at  
A M  
 a n d  
P M 
 
 
 T he 
e ve ni n g d ose will be self-a d mi nistere d b y t he s u bj ect. 
 Perf or m st u d y dr u g acc o u nta bilit y. 
 Verif y t hat t he p ati e nt h as t he necess ar y a m o u nt of st u d y dr u g f or s elf-a d mi nistrati o n Da ys 4, 
5, a n d 6 (a n d D a y 7 [ ± 1 da y] as nee de d). 
 C oll ect bl o o d sa m ples f or t he f oll o wi n g: 
o  C he mistr y, he mat ol o g y, c oa g ulati o n, a n d pr ola cti n. Sa m ple c oll ecte d pre d ose. 
o  P K a nal ysis 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
4 2  
 
 
 
 
 
 
6. 6. 4  
Da ys 4 t o 6 
T he f oll o wi n g pr oce d ures will be perf or me d b y t h e patie nt o n Da ys 4 t o 6: 
 Rec or d c o n c o mita nt me dicati o ns a n d a d verse e v e nts. 
 
 
 Self-a d mi nister st u d y dr u g (all patie nts will ta ke a d ose of bli n de d st u d y dr u g [ CI N- 1 0 2 or 
place b o ca ps ules] orall y at  
A M  
 a n d  
P M 
 
 
 
 
6. 6. 5  
Da y 7 ( ± 1 Da y) 
T he f oll o wi n g pr oce d ures will be perf or me d as a n o ut p atie nt visit o n Da y 7 ( ± 1 da ys): 
 Rec or d c o n c o mita nt me dicati o ns a n d a d verse e v e nts.  
 C oll ect uri ne f or uri nal ysis 
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 Perf or m 1 2-lea d E C G (i n tri plicate a p pr o xi m atel y 1 mi n ute a part after t he patie nt has bee n 
resti n g i n t he s u pi ne p ositi o n f or at least 1 0 mi n utes).  
N ote: 1 2-lea d E C Gs will be pri nte d a n d will be i nter prete d as s o o n as p ossi ble b y t he 
I n v esti gat or. A di gital rec or di n g of eac h E C G will be s u b mitte d t o a ce ntral re vie wer. 
 A d mi nister st u d y dr u g (all patie nts will ta ke a d ose of bli n de d st u d y dr u g [ CI N- 1 0 2 or place b o 
ca ps ules] orall y at  
A M  
 a n d self-a d mi nister orall y at  
P M 
 
 
 
 T h e e ve ni n g d ose will be self-a d mi nistere d b y t he s u bject. 
 Perf or m st u d y dr u g acc o u nta bilit y. 
 Verif y t hat t he p atie nt has t h e necess ar y a m o u nt of st u d y dr u g f or s elf-a d mi nistrati o n f or Da ys 
8 a n d 9 (a n d D a y 1 0 [ ± 1 da y] as nee de d). 
 C oll ect bl o o d sa m ples f or t he f oll o wi n g: 
o  C he mistr y, he mat ol o g y, c oa g ulati o n, a n d pr ola cti n. Sa m ple c oll ecte d pre d ose. 
o  P K a nal ysis 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
4 3  
 
 
 
 
 
 
6. 6. 6  
Da ys 8 t o 9 
T he f oll o wi n g pr oce d ures will be perf or me d b y t h e patie nt o n Da ys 8 a n d 9: 
 Rec or d c o n c o mita nt me dicati o ns a n d a d verse e v e nts. 
 
 
 Self-a d mi nister st u d y dr u g (all patie nts will ta ke a d ose of bli n de d st u d y dr u g [ CI N- 1 0 2 or 
place b o ca ps ules] orall y at  
A M  
 a n d  
P M 
 
 
 
 
6. 6. 7  
Da y 1 0 ( ± 1 Da y) 
T he f oll o wi n g pr oce d ures will be perf or me d as a n o ut p atie nt visit o n Da y 1 0 ( ± 1 da y): 
 Rec or d c o n c o mita nt me dicati o ns a n d a d verse e v e nts.  
 C oll ect uri ne f or uri nal ysis. 
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 Perf or m 1 2-lea d E C G (i n tri plicate a p pr o xi m atel y 1 mi n ute a part after t he patie nt has bee n 
resti n g i n t he s u pi ne p ositi o n f or at least 1 0 mi n utes).  
N ote: 1 2-lea d E C Gs will be pri nte d a n d will be i nter prete d as s o o n as p ossi ble b y t he 
I n v esti gat or. A di gital rec or di n g of eac h E C G will be s u b mitte d t o a ce ntral re vie wer. 
 A d mi nister st u d y dr u g (all patie nt will ta ke a d os e of bli n de d st u d y dr u g [ CI N- 1 0 2 or place b o 
ca ps ules] orall y at  
A M  
 Patie nts will self-a d mi nister st u d y dr u g [ CI N- 1 0 2 or 
place b o ca ps ules] orall y at  
P M 
 
 T he e v e ni n g d os e will be s elf-
a d mi nistere d b y t he s u bject. 
 Perf or m st u d y dr u g acc o u nta bilit y. 
 Verif y t hat t he p atie nt has t h e necess ar y a m o u nt of st u d y dr u g f or s elf-a d mi nistrati o n f or Da ys 
1 1, 1 2, a n d 1 3 (a n d D a y 1 4 [ ± 2 da ys] as nee de d). 
 C oll ect bl o o d sa m ples f or t he f oll o wi n g: 
o  C he mistr y, he mat ol o g y, c oa g ulati o n, a n d pr ola cti n. Sa m ple c oll ecte d pre d ose. 
o  P K a nal ysis 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
4 4  
 
 
 
 
 
 
6. 6. 8  
Da ys 1 1 t o 1 3 
T he f oll o wi n g pr oce d ures will be perf or me d b y t h e patie nt o n Da ys 1 1 t o 1 3: 
 Rec or d c o n c o mita nt me dicati o ns a n d a d verse e v e nts. 
 
 
 Self-a d mi nister st u d y dr u g (all patie nts will ta ke a d ose of bli n de d st u d y dr u g [ CI N- 1 0 2 or 
place b o ca ps ules] orall y at  
A M  
 a n d  
P M 
 
 
 
 
6. 6. 9  
Da y 1 4 ( ± 2 Da ys) 
T he f oll o wi n g pr oce d ures will be perf or me d o n D a y 1 4 ( ± 2 da ys): 
 Rec or d c o n c o mita nt me dicati o ns a n d a d verse e v e nts.  
 C oll ect uri ne sa m ples f or t he f oll o wi n g: 
o  Uri nal ysis.  
o  Uri ne dr u g scree n. 
 Perf or m c o m plete p h ysi cal e xa mi nati o n ( ge neral a p peara n ce, s ki n, hea d, e yes, ears, m o ut h, 
or o p har y n x, nec k, heart, l u n gs, a b d o me n, e xtre mities, a n d ne ur o m usc ular s yste m). 
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 Perf or m 1 2-l ea d E C G 
 
  
N ote: 1 2-lea d E C Gs s h o ul d be perf or me d i n tri plicate a p pr o xi matel y 1 mi n ute a part aft er t he 
patie nt has bee n r esti n g i n t he s u pi ne p ositi o n f or at least 1 0 mi n utes. E C Gs perf or me d after 
t he m or ni n g d ose s h o ul d be c o m plete d ± 1 5 mi n utes fr o m t he s pecifie d ti me p oi nts  
 
 
N ote: 1 2-lea d E C Gs will be pri nte d at sc he d ule d ti me p oi nts a n d will be i nter prete d as s o o n as 
p ossi ble b y t he I n vesti gat or. A di git al rec or di n g of eac h E C G will be s u b mitte d t o a ce ntral 
re vie wer. 
N ote: i n t he e v e nt t he s p o ns or pr o vi d es writt e n a p pr o val t o wai v e o ne or m ore P K sa m ples a n d 
t he s u bject is disc har ge d pri or t o c o m pleti o n of t he  
 P K pr ofile, a n E C G m ust be 
c ollecte d w h e n t he fi nal P K sa m ple is o btai ne d. 
 Assess fasti n g bl o o d gl u c ose will be assesse d b ef ore st u d y dr u g a d mi nistrati o n a n d gastri c 
e m pt yi n g assess me nts t o e ns ure a bl o o d gl u c os e of 2 7 5 m g/ d L. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
4 5  
 
 
 
 
 
 A d mi nister st u d y dr u g (all patie nts will ta ke a d ose of bli n de d st u d y dr u g [ CI N- 1 0 2 or place b o 
ca ps ules] orall y at  
A M 
 Patie nts will fast 
f or a mi ni m u m of 8 h o urs b ef ore t he m or ni n g d ose a n d 4 h o urs after t h e c o m pleti o n of t h e 
G E B T meal. 
 Perf or m st u d y dr u g acc o u nta bilit y a n d c ollect u n use d st u d y dr u g. 
 C oll ect bl o o d sa m ples f or t he f oll o wi n g: 
o  C he mistr y, he mat ol o g y, c oa g ulati o n, a n d pr ola cti n. Sa m ple c oll ecte d pre d ose. 
o  Ser u m pre g na nc y test ( o nl y f or fe males w h o are n ot s ur gicall y sterile or p ost me n o pa usal 
f or at least 1 year [ wit h c o nfir me d F S H i n p ost m e n o pa usal ra n ge at t h e Scree ni n g Visit]). 
o  P K a nal ysis 
 
 
 
 
 
 
 
 
 
 O btai n breat h sa m ples f or G E B T (t wice pri or t o c o ns u m pti o n of a sta n dar diz e d, 
1 3C-e nric he d 
meal a n d t h e n at 4 5, 9 0, 1 2 0, 1 5 0, 1 8 0, a n d 2 4 0 mi n utes after me al c o ns u m pti o n). 
6. 6. 1 0  
Da y 1 5 
T he f oll o wi n g pr oce d ures will be perf or me d as a n o ut p atie nt visit o n Da y 1 5: 
 Rec or d c o n c o mita nt me dicati o ns a n d a d verse e v e nts.  
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 C oll ect bl o o d sa m ples f or P K a nal ysis. 
 Perf or m 1 2-lea d E C G (i n tri plicate a p pr o xi m atel y 1 mi n ute a part after t he patie nt has bee n 
resti n g i n t he s u pi ne p ositi o n f or at least 1 0 mi n utes).  
N ote: 1 2-lea d E C Gs will be pri nte d a n d will be i nter prete d as s o o n as p ossi ble b y t he 
I n v esti gat or. A di gital rec or di n g of eac h E C G will be s u b mitte d t o a ce ntral re vie wer. 
 C oll ect dail y diar y mat erials fr o m patie nt. 
6. 7  
F oll o w- u p Visit ( D a ys 1 6 or 1 7) 
Patie nts will ha ve a fi nal o ut patie nt f oll o w- u p visit 2 t o 3 d a ys ( D a ys 1 6 or 1 7) aft er t h e last d ose 
of st u d y dr u g. T he f oll o wi n g pr o ce d ures will be perf or me d at t he f oll o w- u p visit ( Da ys 1 6 or 1 7): 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
4 6  
 Rec or d pri or a n d c o nc o mita nt me dicati o ns a n d a d verse e v e nts.  
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 C oll ect bl o o d sa m ples f or P K a nal ysis. 
6. 8  
E arl y Ter mi n ati o n Visit a n d Wit h dr a w al Pr oce d ures 
F or p atie nts w h o are wit h dra w n fr o m t he st u d y pri or t o c o m pleti o n, t h e f oll o wi n g pr oce d ures will 
be perf or me d at t h e E arl y Ter mi nati o n Visit: 
 O btai n breat h sa m ples f or G E B T (t wice pri or t o c o ns u m pti o n of a sta n dar diz e d, 
1 3C-e nric he d 
meal a n d t h e n at 4 5, 9 0, 1 2 0, 1 5 0, 1 8 0, a n d 2 4 0 mi n utes after me al c o ns u m pti o n). 
 Rec or d pri or a n d c o nc o mita nt me dicati o ns a n d a d verse e v e nts.  
 C oll ect uri ne sa m ples f or t he f oll o wi n g: 
o  Uri nal ysis 
o  Uri ne dr u g scree n  
 Perf or m c o m plete p h ysi cal e xa mi nati o n ( ge neral a p peara n ce, s ki n, hea d, e yes, ears, m o ut h, 
or o p har y n x, nec k, heart, l u n gs, a b d o me n, e xtre mities, a n d ne ur o m usc ular s yste m). 
 O btai n vital si g ns (i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure) w hil e 
patie nt is sitti n g after a mi ni m u m 5- mi n ute rest. 
 Perf or m 1 2-lea d E C G (i n tri plicate a p pr o xi m atel y 1 mi n ute a part after t he patie nt has bee n 
resti n g i n t he s u pi ne p ositi o n f or at least 1 0 mi n utes).  
N ote: 1 2-lea d E C Gs will be pri nte d a n d will be i nter prete d as s o o n as p ossi ble b y t he 
I n v esti gat or. A di gital rec or di n g of eac h E C G will be s u b mitte d t o a ce ntral re vie wer. 
 Perf or m st u d y dr u g acc o u nta bilit y a n d c ollect u n use d st u d y dr u g. 
 C oll ect bl o o d sa m ples f or t he f oll o wi n g: 
o  C he mistr y, he mat ol o g y, c oa g ulati o n, a n d pr ola cti n.  
o  Ser u m pre g na nc y test ( o nl y f or fe males w h o are n ot s ur gicall y sterile or p ost me n o pa usal 
f or at least 1 year [ wit h c o nfir me d F S H i n p ost m e n o pa usal ra n ge]). 
o  P K a nal ysis. 
 
 
 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
4 7  
7  
E F FI C A C Y A S S E S S M E N T S 
7. 1  
Pri m ar y Effic ac y Assess me nt 
T he pri mar y efficac y varia ble is t he c ha n ge fr o m baseli n e ( gat here d o n D a ys - 7 t o - 2) i n gastri c 
e m pt yi n g as meas ure d b y G E B T at Da y 1 4 ( ± 2 da ys).  
T he G E B T is a n o nra di o acti v e st a ble is ot o pe breat h test, i n w hic h t he rati o of e x hale d 1 3C O 2/1 2C O 2 
is use d t o deter mi n e t h e rate of gastric e m pt yi n g after c o ns u m pti o n of a sta n dar diz e d, 1 3C-e nric he d 
meal. Patie nts will c o ns u me a st a n d ar dize d, 
1 3C-e nric h e d meal after a n 8- h o ur fast at bas eli ne 
( Da ys - 7 t o - 2) a n d after a n 8- h o ur fast starti n g 3 0 mi n utes after st u d y dr u g a d mi nistrati o n o n 
Da y 1 4 ( ± 2 d a ys). Breat h sa m ples will b e o btai ne d t wice pri or t o c o ns u m pti o n of a sta n dar dize d, 
1 3C-e nric he d m eal a n d t h e n at 4 5, 9 0, 1 2 0, 1 5 0, 1 8 0, a n d 2 4 0 mi n utes after m eal c o ns u m pti o n after 
a n 8- h o ur fast o n Da ys - 7 t o - 2 a n d Da y 1 4 ( ± 2 da ys) a n d 3 0 mi n utes after st u d y dr u g a d mi nistrati o n 
o n Da y 1 4 ( ± 2 da ys). 
7. 2  
Sec o n d ar y Effic ac y Assess me nt 
T he sec o n d ar y efficac y v aria bles are t h e f oll o wi n g: 
 T he c ha n ge fr o m baseli n e i n gastric e m pt yi n g as meas ure d b y G E B T t 1/ 2 ( B T t 1/ 2)  at Da y 1 4 
( ± 2 da ys) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7. 3  
E x pl or at or y Effic ac y Assess me nt 
 
 
 
  
 
  
 
 
  
 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
4 8  
 
 
 
 
 
  
 
  
  
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
7. 4  
P h a r m a c o ki netics 
Bl o o d sa m ples f or P K a nal yses will b e c ollect e d pri or t o t h e m or ni n g d ose 
 
 a n d 
at 
 after t he m or ni n g d ose o n Da ys 1 a n d 1 4 ( ± 2 da ys), o nl y. Bl o o d 
sa m ples f or P K a n al ys es will als o be c olle cte d o ver 
 after t he fi nal d ose o n 
Da y 1 4 ( ± 2 
da ys). 
T h e f oll o wi n g 
wi n d o ws 
will 
be 
per mitte d f or t he c oll ecti o n 
of 
P K sa m ples: 
 
 
  
T he f oll o wi n g P K para m eters will be calc ulate d f or de uterate d d o m peri d o ne (a n d a n y meas ure d 
meta b olites) usi n g plas ma c o nce ntr ati o ns meas ure d f oll o wi n g CI N- 1 0 2 d oses o n D a y 1 if t he data 
per mit: 
 C ma x  
 Ti me t o ma xi m u m plas ma c o nce ntrati o n 
 A U C o ver a d osi n g i nter val 
T he f oll o wi n g P K para m eters will be calc ulate d f or de uterate d d o m peri d o ne (a n d a n y meas ure d 
meta b olites) usi n g plas ma c o nce ntrati o ns meas ure d f oll o wi n g t he fi nal d ose of CI N- 1 0 2, if t he 
data p er mit: 
 C ma x  
 Ti me t o ma xi m u m plas ma c o nce ntrati o n 
 A U C o ver a d osi n g i nter val 
 A U C fr o m ti me 0 t o t he ti me of t h e last q ua ntifia ble plas m a c o nce ntrati o n 
 A U C fr o m ti me 0 t o i nfi nit y 
 Perce nt of A U C e xtra p olate d 
 T ½  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
4 9  
 A p pare nt plas ma cleara nce 
 A p pare nt v ol u me of distri b uti o n 
Tr o u g h c o n ce ntr ati o ns c oll ecte d t hr o u g h o ut t he st u d y will be use d t o c o nfir m c o m plia nce a n d 
attai n me nt of stea d y-stat e. 
7. 5  
P h a r m a c o ge n o mic Assess me nts 
A si n gle, o pti o nal P G x bl o o d sa m ple m a y be c ollecte d at a n y ti me d uri n g t he patie nt’s parti ci pati o n 
i n t h e st u d y. T he P G x sa m ples ma y be us e d f or ge netic researc h t o e x pl ore t he u n d erl yi n g ca uses 
of varia bilit y a n d/ or differe nces i n res p o nse i n P K, P D, a n d/ or safet y data f oll o wi n g a d mi nistrati o n 
of CI N- 1 0 2. Patie nts will b e gi v e n t he o pti o n t o partici pate i n t he P G x assess m e nt d uri n g t he 
c o nse nti n g pr ocess f or t h e st u d y. I n or der t o h a ve a P G x sa m ple c ollecte d, patie nts m ust pr o vi de 
writte n i nf or me d c o nse nt t o partici pate, w hic h is i ncl u de d i n t he mai n I C F. T he patie nt ma y 
wit h dra w c o nse nt t o partici pate i n t he P G x assess me nt at a n y ti me d uri n g t he st u d y wit h o ut 
wit h dra wi n g c o ns e nt t o p artici pate i n t he st u d y. Se e Secti o n 7. 5. 1 f or det ails re gar di n g sa m ple a n d 
data destr ucti o n f oll o wi n g wit h dra wal of c o ns e nt. T he de o x yri b o n ucleic aci d sa m ple will n ot be 
i m m ortalize d, s ol d t o a n y o ne, or s u b mitte d t o a p u blic ge netic data bas e. T h e res ults o btai ne d fr o m 
a nal ysis of t h e P G x sa m ples will b e accessi ble t o t he S p o ns or, t he part y(i es) perf or mi n g s a m ple 
a n d/ or data a nal yses, a n d t he part y i n v ol ve d i n mai nte na nce of t he S p o ns or’s data base. T he res ults 
ma y b e dis cl ose d t o t h e I n vesti gat or b ut are n ot i nte n de d t o be pr o vi d e d t o t he p atie nt. T he P G x 
res ults ma y b e re p ort e d a n d/ or p u blis he d wit h o ut a n y of t h e patie nt’s pers o nal i d e ntificati o n 
i nf or mati o n. 
7. 5. 1  
C oll ecti o n, St ora ge, a n d Destr ucti o n of P har mac o ge n o mic Sa m ples  
F or p atie nts w h o pr o vi de writte n i nf or m e d c o ns e nt t o partici pate i n t he o pti o nal P G x assess m e nt, 
a bl o o d sa m ple will be c ollecte d at a n y ti me d uri n g t he patie nt’s partici pati o n i n t he st u d y. T he 
date a n d ti me of sa m ple c oll ecti o n will be d oc u m e nte d i n t he patie nt’s s o urce d o c u me nts. Eac h 
sa m ple m ust be la bele d wit h a u ni q ue i d e ntifier. G o o d La b orat or y Pr acti ce re q uires a c hai n of 
c ust o d y t h at is tracea ble t o t h e sa m ple d o n or. T o e ns ure patie nt c o nfi de nti alit y, sa m ple t u b es will 
be i de ntifie d b y patie nt i de ntificati o n n u m ber o nl y. 
Sa m ples will be retai ne d u ntil e x ha uste d or u ntil t h e S p o ns or re q uests destr ucti o n. If t he p atie nt 
wit h dra ws c o nse nt, t he bl o o d sa m ples will be pr o m ptl y ma na ge d re gar di n g pr o per dis p ositi o n. 
H o we ver, t he data will n ot be discar de d if ge n etic a nal ysis has bee n c o m pl ete d bef ore t he patie nt 
wit h dra ws c o nse nt. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
5 0  
8  
S A F E T Y A S S E S S M E N T S 
8. 1  
A d verse E ve nts 
A n a d vers e e v e nt is defi n e d as a n y u nt o w ar d m e di cal occ urre n ce i n a cli nic al i n vesti gati o n patie nt 
a d mi nistere d a p h ar mace utical pr o d uct, w hic h d o es n ot necessaril y h a ve a ca usal relati o ns hi p wit h 
t his treat m e nt. A n a d v erse e v e nt ca n t heref ore be a n y u nfa v ora ble a n d/ or u ni nte n de d si g n 
(i ncl u di n g a n a b n or m al l a b orat or y fi n di n g), s y m pt o m, or dis ease te m p orall y ass ociate d wit h t he 
use of a n i n vesti gati o nal me dici n al pr o d uct w het h er or n ot relate d t o t he i n vesti gati o nal me dici n al 
pr o d uct. All a d vers e e ve nts, i n cl u di n g o bser ve d or v ol u nteere d pr o ble ms, c o m plai nts, or 
s y m pt o ms, are t o be rec or de d o n t h e a p pr o priate e C R F. 
A d vers e e v e nts, 
w hic h i ncl u de cli nical la b orat or y test varia bles, 
will be 
m o nit ore d a n d 
d oc u me nte d fr o m t he ti me of first d ose of st u d y dr u g u ntil parti ci pati o n is c o m plete. Patie nts 
s h o ul d be i nstr ucte d t o re p ort a n y a d verse e v e nt t hat t he y e x perie nc e t o t he I n vesti g at or a n d/ or 
rele va nt site staff w het her or n ot t he y t hi n k t he e v e nt is d ue t o st u d y treat me nt. Be gi n ni n g at t he 
ti m e of first d ose of st u d y dr u g, I n vesti gat ors s h o ul d m a ke a n assess me nt f or a d v erse e ve nts at 
eac h visit a n d rec or d t h e e ve nt o n t he a p pr o priate a d verse e ve nt e C R F. 
W h ere ver p ossi ble, a s p ecific disease or s y n dr o me rat h er t h a n i n di vi d ual ass ociate d si g ns a n d 
s y m pt o ms s h o ul d b e i d e ntifie d b y t he I n vesti gat or a n d rec or de d o n t he e C R F. H o w e ver, if a n 
o bser ve d or re p orte d si g n or s y m pt o m is n ot c o nsi d ere d a c o m p o ne nt of a s pecific disease or 
s y n dr o me b y t he I n v esti gat or, it s h o ul d be rec or de d as a s e parate a d vers e e ve nt o n t he e C R F. 
A d diti o nall y, t h e c o n diti o n t hat le d t o a me dical or s ur gical pr o ce d ure (e g, s ur ger y, e n d os c o p y, 
t o ot h e xtracti o n, or tra nsf usi o n) s h o ul d be rec or de d as a n a d verse e ve nt, n ot t he pr oce d ure its elf.  
A n y me dical c o n diti o n alrea d y prese nt at t he ti me of first d ose of st u d y dr u g s h o ul d be rec or d e d 
as me dical hist or y a n d n ot be re p orte d as a n a d verse e ve nt u nless t he m e dical c o n diti o n or si g ns 
or s y m pt o ms pres e nt at b aseli ne c ha n ges i n se v erit y, fre q u e nc y, or seri o us n ess at a n y ti m e d uri n g 
t he st u d y. I n t his case, it s h o ul d be re p orte d as a n a d verse e ve nt. 
Cli nicall y si g nifica nt a b n or mal la b orat or y or ot her e xa mi nati o n (e g, E C G) fi n di n gs t h at are 
detecte d d uri n g t h e st u d y or are pres e nt at t he ti me of first d ose of st u d y dr u g a n d si g nifica ntl y 
w orse n d uri n g t he st u d y s h o ul d be re p orte d as a d verse e ve nts, as d escri b e d b el o w. T he I n vesti gat or 
will e xercise his or h er me dical a n d scie ntific j u d g m e nt i n deci di n g w het her a n a b n or mal 
la b orat or y fi n di n g, or ot her a b n or mal assess me nt is cli nicall y si g nifica nt. Cli nicall y si g nifica nt 
a b n or mal la b orat or y v al ues occ urri n g d uri n g t h e cli nical st u d y will be f oll o we d u ntil re peat tests 
ret ur n t o n or mal, sta bilize, or are n o l o n ger cli nicall y si g nifica nt. A b n or mal test res ults t hat are 
deter mi n e d t o be a n err or s h o ul d n ot be re p orte d as a n a d verse e v e nt. La b orat or y a b n or malities or 
ot her a b n or mal cli nical fi n di n gs (e g, E C G a b n or maliti es) s h o ul d be re p orte d as a n a d verse e ve nt 
if a n y of t he f oll o wi n g are a p plica ble: 
 If a n i nter v e nti o n is re q uire d as a res ult of t he a b n or malit y 
 If acti o n wit h t he st u d y dr u g is r e q uire d as a res ult of t h e a b n or malit y 
 Base d o n t h e cli nical j u d g me nt of t he I n vesti gat or 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
5 1  
8. 1. 1  
A d vers e ( Dr u g) Re acti o n 
All n o xi o us a n d u ni nte n de d res p o nses t o a me dici nal pr o d uct relate d t o a n y d ose s h o ul d be 
c o nsi dere d a n a d vers e dr u g reacti o n. “ Res p o nses” t o a me dici nal pr o d uct mea ns t hat a ca usal 
relati o ns hi p bet w ee n a me di ci nal pr o d u ct a n d a n a d verse e ve nt is at least a reas o na bl e p ossi bilit y, 
ie, t he relati o ns hi p ca n n ot be r ule d o ut. 
8. 1. 2  
U ne x pecte d A d verse Dr u g R eacti o n 
A n U ne x pecte d A d verse Dr u g Reacti o n is defi ne d as a n a d verse reacti o n, t he nat ure or se verit y of 
w hic h is n ot c o nsiste nt wit h t h e a p plica ble pr o d uct i nf or mati o n. 
8. 1. 3  
Assess me nt of A d vers e E ve nts b y t h e I n vesti gat or 
T he I n vesti gat or will ass ess t he se verit y (i nte nsit y) of all a d verse e ve nts (seri o us a n d n o n-seri o us) 
a n d will be gra de d usi n g t he C T C A E Versi o n 5. 0 criteria as s h o w n i n Ta ble 1. T he I n vesti gat or 
will als o cate g orize eac h a d vers e e v e nt as t o its p ote ntial relati o ns hi p t o st u d y dr u g usi n g t he 
cate g ories of yes or n o. 
T a bl e 1.     C T C A E Se verit y Assess me nt of A d verse E v e nts 
Gra de  
Se verit y  
D escri pti o n 
1 
Mil d 
As y m pt o matic or mil d s y m pt o ms; cli nical or dia g n ostic o bser vati o ns o nl y; 
i nter ve nti o n n ot i n dicate d 
2  
M o d erate 
Mi ni mal, l ocal or n o ni n vasi v e i nter ve nti o n i n dicate d; li miti n g a ge-a p pr o priate 
i nstr u me ntal acti vities of dail y li vi n g * 
3  
Se vere 
Se vere 
or 
me dicall y si g nifica nt 
b ut 
n ot i m me diatel y life-t hreate ni n g; 
h os pitalizati o n or pr ol o n gati o n of h os pitalizati o n i n dicate d; disa bli n g; li miti n g 
self-care acti vities of d ail y li vi n g * * 
4  
Life T hreate ni n g 
Life t hreate ni n g c o nse q ue nces; ur ge nt i nter ve nti o n i n dicate d 
5 
Deat h  
Deat h relate d t o A E 
*I nstr u me nt al acti vities of dail y li vi n g refer t o pre pari n g meals, s h o p pi n g f or gr oceries or cl ot h es, usi n g t h e t ele p h o n e, ma n a gi n g m o ne y, et c. 
* * Self-care acti viti es of d ail y li vi n g refer t o b at hi n g, dressi n g a n d u n dressi n g, fee di n g self, usi n g t h e t oilet, t a ki n g me dicati o ns, a n d n ot 
b e dri d d e n . 
Ref: htt ps://cte p.ca n cer. g o v/ pr ot oc ol De v el o p me nt/ el ectr o ni c _a p pli cati o ns/ d ocs/ C T C A E _ v 5 _ Q uic k _ R efere nce _ 5 x 7. p df   
 
Ca usalit y assess me nt: 
T he rel ati o ns hi p of a n a d verse e ve nt t o t he a d mi nistrati o n of t he st u d y dr u g is t o be assesse d 
acc or di n g t o t he f oll o wi n g defi niti o ns: 
N o ( u nrelate d, n ot relate d, u nli kel y t o be relate d) – T he ti m e c o urse bet wee n t he a d mi nistrati o n of 
st u d y dr u g a n d t he o cc urre nce or w orse ni n g of t he a d vers e e ve nt r ul es o ut a ca usal relati o ns hi p 
a n d a n ot h er ca use (c o nc o mit a nt dr u gs, t hera pies, c o m plicati o ns, etc.) is s us pect e d. 
Yes ( p ossi bl y, pr o b a bl y, or defi nitel y relate d) – T he ti m e c o urse bet w ee n t he a d mi nistrati o n of 
st u d y dr u g a n d t he o cc urre nce or w ors e ni n g of t he a d vers e e ve nt is c o nsiste nt wit h a ca usal 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
5 2  
relati o ns hi p a n d n o ot her ca use (c o nc o mita nt dr u gs, t hera pies, c o m plicati o ns, etc.) ca n b e 
i de ntifie d. 
T he defi niti o n i m plies a reas o na bl e p ossi bilit y of a ca usal relati o ns hi p bet w ee n t h e e ve nt a n d t he 
st u d y dr u g. T his mea ns t hat t h ere are facts (e vi d e nce) or ar g u m e nts t o s u g gest a ca usal relati o ns hi p. 
T he f oll o wi n g fact ors s h o ul d als o be c o nsi d ere d: 
 T he te m p oral se q u e nce fr o m st u d y dr u g a d mi nistrati o n- 
o  T he e ve nt s h o ul d occ ur after t he st u d y dr u g is gi v e n. T he le n gt h of ti me fr o m st u d y dr u g 
e x p os ure t o e ve nt s h o ul d be e val uate d i n t he cli nical c o nte xt of t he e ve nt. 
 U n derl yi n g, c o nc o mit a nt, i nterc urre nt diseases- 
o  Eac h re p ort s h o ul d be e val uate d i n t he c o nte xt of t h e nat ural hist or y a n d c o urse of t he 
disease bei n g treate d a n d a n y ot h er dis eas e t he patie nt ma y h a ve. 
 C o nc o mita nt dr u g- 
o  T he ot her dr u gs t h e patie nt is ta ki n g or t he treat m e nt t he patie nt recei ves s h o ul d be 
e x a mi ne d t o deter mi ne w het her a n y of t h e m mi g ht be rec o g niz e d t o ca use t h e e ve nt i n 
q uesti o n. 
 K n o w n res p o nse p atter n f or t his class of st u d y dr u g- 
o  Cli nical a n d/ or precli nical data ma y i n dicate w het her a partic ul ar res p o nse is li k el y t o b e a 
class effect. 
 E x p os ure t o p h ysi cal a n d/ or me ntal stresses- 
o  T he e x p os ure t o stress mi g ht i n d uce a d v erse c ha n ges i n t he reci pie nt a n d pr o vi de a l o gical 
a n d better e x pla nati o n f or t he e ve nt. 
 T he p har ma c ol o g y a n d P K of t h e st u d y dr u g- 
o  T he k n o w n p h ar m ac ol o gi c pr o perties (a bs or pti o n, distri b uti o n, meta b olis m, a n d e x creti o n) 
of t he st u d y dr u g s h o ul d be c o nsi dere d. 
8. 2  
Seri o us A d v erse E ve nts 
A n a d vers e e v e nt or a d verse reacti o n is c o nsi dere d seri o us if, i n t h e vie w of eit her t he I n vesti g at or 
or S p o ns or, it res ults i n a n y of t he f oll o wi n g o ut c o mes: 
 Deat h. 
 A life-t hreate ni n g a d verse e ve nt. 
N ote: A n a d verse e v e nt or a d verse reacti o n is c o nsi dere d “life-t hreate ni n g” if, i n vie w of eit her 
t he I n vesti gat or or S p o ns or, its occ urre nce places t h e patie nt at i m m e diate ris k of d eat h. It d oes 
n ot i n cl u de a n e ve nt t hat, ha d it occ urre d i n a m ore se vere f or m, mi g ht ha v e ca use d d eat h. 
 Re q uires h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pit alizati o ns. 
N ote: A n y h os pital a d missi o n wit h at least 1 o ver ni g ht sta y will be c o nsi dere d a n i n patie nt 
h os pitalizati o n. A n e mer ge nc y r o o m or ur ge nt care visit wit h o ut h os pital a d missi o n will n ot 
be rec or de d as a S A E u n der t his criteri o n, n or will h os pitalizati o n f or a pr oce d ure sc h e d ule d 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
5 3  
or pla n ne d bef ore si g ni n g of i nf or me d c o ns e nt, or electi v e treat me nt of a pre- e xisti n g c o n diti o n 
t hat di d n ot w orse n fr o m Baseli n e. H o w e ver, u n e x pecte d c o m plicati o ns a n d/ or pr ol o n gati o n 
of h os pitalizati o n t hat o cc ur d uri n g electi v e s ur ger y s h o ul d be rec or de d as a d verse e ve nts a n d 
assess e d f or seri o us ness. A d missi o n t o t he h os pital f or s o cial or sit uati o nal reas o ns (ie, n o place 
t o sta y, li ve t o o far a wa y t o c o me f or h os pit al visits, res pite care) will n ot be c o nsi d ere d 
i n patie nt h os pitalizati o ns.  
 A persiste nt or si g nifica nt disa bilit y/i nca pacit y or s u bsta ntial disr u pti o n of t he a bilit y t o 
c o n d uct n or mal life f u n cti o ns. 
 A c o n ge nit al a n o mal y/ birt h defect. 
 A n i m p orta nt me dical e v e nt. 
N ote: I m p ort a nt me dical e ve nts t hat d o n ot meet a n y of t he a b o ve criteria ma y be c o nsi dere d 
a n S A E w he n, base d u p o n a p pr o priate m e dic al j u d g me nt, t he y ma y je o p ar dize t he patie nt a n d 
ma y re q uire m e dical or s ur gical i nter ve nti o n t o pre v e nt 1 of t he o utc o mes liste d a b o ve. 
E x a m ples of s uc h m e dical e ve nts i ncl u de aller gic br o nc h os pas m re q uiri n g i nte nsi ve treat m e nt 
i n a n e mer ge nc y r o o m or at h o m e, bl o o d d ys crasias or c o n v ulsi o ns t hat d o n ot res ult i n 
i n patie nt h os pitalizati o ns, or t he de vel o p me nt of dr u g d e pe n de n c y. 
8. 3  
Seri o us A d v erse E ve nt Re p orti n g − Pr oce d ures f or I n vesti g at ors 
I niti al Re p orts 
All S A Es occ urri n g fr o m t he ti me of first d ose of st u d y dr u g u ntil 3 0 da ys f oll o wi n g t he fi nal d ose 
of st u d y dr u g m ust be re p orte d t o 
 wit hi n 2 4 h o urs of t h e k n o wle d ge of 
t he occ urre nce. After t h e 3 0- da y re p orti n g wi n d o w, a n y S A E t hat t he I n vesti gat or c o nsi ders rel ate d 
t o st u d y dr u g m ust be re p orte d t o 
 or t h e S p o ns or/ desi g n ee. Of n ot e, 
re p orti n g of S A Es aft er t he f oll o w- u p p h o ne call 7 2 h o urs after disc har ge is de pe n de nt o n 
s p o nta ne o us re p orti n g b y t h e patie nt. T he I n vesti gat or is n ot re q uire d t o ha ve f urt her c o ntact t o 
elicit t his i nf or mati o n after c o m pleti o n of t he f oll o w- u p p h o ne call b ut s h o ul d i nstr uct t he patie nt 
t o c o ntact t h e sit e t o re p ort a n y s u c h e v e nts.  
T o re p ort t h e S A E, c o m plete t h e S A E f or m el ectr o nicall y i n t he electr o nic data ca pt ure ( E D C) 
s yste m f or t h e st u d y. W h e n t h e f or m is c o m plet e d, 
 pers o n nel will be n otifie d 
electr o nicall y b y t h e E D C s yst e m a n d will retrie v e t he f or m. If t he e ve nt m eets seri o us criteria a n d 
it is n ot p ossi ble t o access t he E D C s yste m, se n d a n e- mail t o 
 at 
 or call t he 
 re p orti n g li ne ( p h o n e 
n u m ber liste d bel o w), a n d fa x/ e- mail t he c o m plete d pa per S A E f or m t o  
 (fa x n u m ber 
liste d b el o w) wit hi n 2 4 h o urs of a ware ness. W h e n t he E D C s yste m bec o mes a vaila ble, t h e S A E 
i nf or mati o n m ust be e ntere d wit hi n 2 4 h o urs of t h e s yste m b ec o mi n g a vail a ble. 
Safet y C o ntact I nf or m ati o n: 
 
 
 
 
 
F oll o w- U p Re p orts 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
5 4  
T he I n vesti gat or m ust c o nti n ue t o f oll o w t he patie nt u ntil t he S A E has s u bsi de d or u ntil t h e 
c o n diti o n bec o mes c hr o ni c i n nat ure, sta bilizes (i n t he case of persiste nt i m pair me nt), or t he patie nt 
dies. 
Wit hi n 2 4 h o urs of recei pt of f oll o w- u p i nf or mati o n, t he I n v esti gat or m ust u p date t he S A E f or m 
electr o nicall y i n t he E D C s yste m f or t he st u d y a n d s u b mit a n y s u p p orti n g d o c u me nt ati o n 
(e g, patie nt disc har ge s u m mar y or a ut o ps y re p orts) t o 
 via fa x or e- mail. 
If it is n ot p ossi ble t o access t h e E D C s yst e m, refer t o t he pr oce d ures o utli ne d a b o ve f or i nitial 
re p orti n g of S A Es. 
8. 4  
Pre g n a nc y Re p orti n g 
If a pati e nt bec o mes pre g na nt d uri n g t he st u d y or wit hi n t he safet y f oll o w- u p peri o d defi n e d i n t he 
pr ot oc ol, t he I n v esti gat or is t o st o p d osi n g wit h st u d y dr u g(s) i m me diatel y a n d t he patie nt s h o ul d 
be wit h dra w n fr o m t he st u d y. Earl y ter mi n ati o n pr oce d ures s h o ul d b e i m ple me nte d at t hat ti me.  
A pre g n a nc y is n ot c o nsi dere d t o be a n a d verse e ve nt or S A E; h o we ver, it m ust be re p orte d t o 
 wit hi n 2 4 h o urs of k n o wle d g e of t he e v e nt. 
 will 
t he n pr o vi de t he I n vesti gat or/site t he E x p os ure I n Uter o ( EI U) f or m f or c o m pleti o n. T he 
I n v esti gat or/site m ust c o m plete t he EI U f or m a n d fa x or e- mail it bac k t o 
.  
If t he fe m ale p art ner of a male p atie nt bec o mes pre g n a nt w hile t he p atie nt is recei vi n g st u d y dr u g 
or wit hi n t h e safet y f oll o w- u p peri o d d efi ne d i n t he pr ot oc ol, t he I n vesti gat or s h o ul d n otif y 
 as descri be d a b o ve.  
T he pre g na n c y s h o ul d be f oll o we d u ntil t he o utc o me of t he pre g na n c y, w h e ne ver p ossi ble. O n ce 
t he o utc o me of t h e pre g n a nc y is k n o w n, t he EI U f or m s h o ul d be c o m plete d a n d f a xe d/e- maile d t o 
. If t he o utc o m e of t h e pre g na nc y meets t he criteria f or i m me diate 
classificati o n as a n S A E (ie, p ost part u m c o m plicati o n, s p o nta ne o us a b orti o n, still birt h, ne o natal 
deat h, or c o n ge nital a n o mal y), t he I n v esti g at or s h o ul d f oll o w t he pr o ce d ures f or re p orti n g a n S A E. 
8. 5  
E x pe dite d Re p orti n g 
T he S p o ns or will re p ort all rele va nt i nf or mati o n a b o ut s us pecte d u ne x pecte d seri o us a d vers e 
reacti o ns t hat are fat al or life-t hreate ni n g as s o o n as p ossi ble t o t he F D A a n d i n a n y case n o l ater 
t ha n 7 da ys after k n o wle d ge b y t he S p o ns or/ desi g nee of s uc h a case, a n d t he rele v a nt f oll o w- u p 
i nf or mati o n will s u bse q ue ntl y be c o m m u nicate d wit hi n a n a d diti o nal 8 da ys.  
All ot h er s us p ecte d u ne x pecte d s eri o us a d vers e reacti o ns will be re p orte d t o t he F D A as s o o n as 
p ossi ble b ut wit hi n a ma xi m u m of 1 5 da ys of first k n o wle d ge b y t he S p o ns or/ desi g n ee.  
T he S p o ns or/ desi g n ee will als o i nf or m all I n v esti gat ors as re q uire d. 
8. 6  
Cli ni c al L a b or at or y E v al u ati o ns 
Safet y l a b orat or y tests will i n cl u de c he mistr y, he m at ol o g y, c o a g ulati o n, pr olacti n, a n d uri nal ysis. 
See A p p e n di x B  f or a c o m plete list of a nal ytes.  
Safet y la b orat or y tests will b e e val uate d at t he ti mes i n dicate d i n t h e Sc he d ule of Pr oce d ures ta bl e 
i n A p pe n di x A .  
A b n or mal scree ni n g la b orat or y tests ma y b e re peate d n o m ore t ha n 2 ti mes f or eli gi bilit y p ur p oses.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
5 5  
If, i n t he o pi ni o n of t he I n vesti gat or, a n y p atie nt has a cli nicall y si g nifica nt a b n or mal la b orat or y 
fi n di n g i n c o m p aris o n t o t he val ue at t h e ti m e of ra n d o mizati o n or u nres ol v e d T E A Es, a d diti o nal 
f oll o w- u p visits will be s c he d ule d. Patie nts will b e f oll o we d a p pr o xi matel y o n ce a w ee k ( or m ore 
fre q ue ntl y as d ee me d a p pr o pri ate) u ntil t h e I n vesti gat or d eter mi n es t h at re p eat la b orat or y fi n di n gs 
are cli nicall y u nre m ar ka ble i n c o m paris o n t o baseli ne, or u nres ol ve d a d verse e ve nts ret ur n t o 
prest u d y l e vels or cli nicall y acce pta ble l e vels. 
If a patie nt e x perie nces a n S A E f or w hi c h f oll o w- u p l a b orat ories a n d re vie w are re q uire d, t h e 
I n v esti gat or will sc he d ul e a d diti o nal p ost d ose visits as necess ar y. 
If, i n t he o pi ni o n of t he I n vesti gat or, a n y patie nt has a cli nicall y si g nifica nt a d verse e ve nt at t h e 
f oll o w- u p call, t he I n vesti gat or will pr o vi d e a d diti o nal f oll o w- u p u ntil t h e a d verse e v e nt ret ur ns t o 
cli nicall y acce pta ble le vels. 
T he safet y la b orat or y sa m ple c ollecti o n ti mes m a y be refi ne d b ase d o n e mer gi n g data t o e ns ure 
st u d y o bjecti ves are met. 
8. 7  
Vit al Si g ns 
Vital si g ns, i ncl u di n g heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure, will be meas ure d 
at t he ti mes i n dicate d i n t he Sc he d ule of Pr o ce d ures ta ble i n A p pe n di x A usi n g t he f oll o wi n g 
sta n dar diz e d pr oce d ures: 
 Pri or t o meas uri n g vit al si g ns, t he patie nt s h o ul d be sitti n g f or a mi ni m u m of 5 mi n utes wit h 
his/ h er bac k s u p p orte d, feet flat o n t he fl o or, a n d his/ h er m eas ure m e nt ar m s u p p orte d s o t hat 
t he mi d p oi nt of t he m a n o meter c uff is at heart le vel. 
 A n a p pr o priat el y size d c uff s h o ul d be use d wit h t he bla d der ce ntere d o ver t he brac hial arter y. 
 T he c uff size a n d ar m use d f or t he meas ure m e nt s h o ul d be rec or de d. W he n e ver p ossi ble, t he 
sa me ar m s h o ul d be use d f or all vital si g n ass ess me nts t hr o u g h o ut t he st u d y. 
 Bl o o d press ure s h o ul d be rec or d e d t o t he nearest w h ole n u m ber o n a n a ut o matic de vice. 
8. 8  
Electr oc a r di o gr a ms 
T wel ve-lea d E C Gs will b e perf or me d at t he ti mes i n dicat e d i n t h e Sc he d ul e of Pr oce d ures t a bl e i n 
A p pe n di x A.  
E ver y eff ort will be ma de t o eli mi nate a n y s o urces of p h ysical (i n cl u di n g a n y m o ve me nt, eati n g, 
or dri n ki n g) or electri cal i nterfere nce. D uri n g t hese assess me nts, patie nts are n ot per mitte d t o use 
cell p h o nes, i P o ds, la pt o p c o m p uters, ta blets, or a n y t y pe of batter y- o p erat e d or electri cal de vice, 
a n d all of t h ese d e vices m ust be t ur ne d off d uri n g t h e assess me nts. 
All 1 2-lea d E C Gs will be perf or me d i n tri plicate a p pr o xi m atel y 1 mi n ute a part after t he patie nt 
has bee n resti n g i n t he s u pi ne p ositi o n f or at least 1 0 mi n utes. T he a vera ge Q Tc F will be use d f or 
eli gi bilit y a n d safet y ass ess m e nts. T wel ve-lea d E C Gs will be pri nte d a n d will be i nter prete d as 
s o o n as p ossi ble b y a n I n v esti gat or ( or S u bi n vesti gat or f or S cree ni n g Visit o nl y). All E C Gs 
c ollecte d at t he ti me of ra n d o mizati o n a n d t hr o u g h o ut t he treat m e nt peri o d m ust be e val uate d f or 
t he prese nce of a b n or m aliti es b y a q ualifie d p h ysicia n. A di gital rec or di n g of all E C Gs f or 
ra n d o mize d s u bjects will be s u b mitt e d t o a ce ntral re vie w er. T he ce ntr al o v errea d E C G dat a will 
be utiliz e d f or all safet y assess me nts a n d a nal yses. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
5 6  
Sta n dar d E C G para meters will be meas ure d, a n d t he f oll o wi n g E C G p ara meters will be rec or d e d: 
 Q R S i nter val 
 Heart rate 
 R R i nter val 
 Q T i nter val 
 Q Tc ( Q T c F) 
I n v esti gat ors s h o ul d c o ntact t he S p o ns or or desi g nee if a n y cli nicall y mea ni n gf ul c ha n ges fr o m 
baseli n e are n ote d o n re vie w. Please refer t o A p pe n di x C f or E C G alert criteria g ui da nce. 
8. 9  
P h ysic al E x a mi n ati o ns 
C o m plete p h ysical e x a mi nati o ns will be perf or m e d at t h e ti mes i n dicate d i n t he Sc h e d ule of 
Pr oce d ures t a ble i n A p pe n di x A . A c o m plete p h ysical e x a mi n ati o n will c o nsist of ge neral 
a p peara nce, s ki n, h ea d, e yes, ears, m o ut h, or o p h ar y n x, nec k, heart, l u n gs, a b d o me n, e xtre mities, 
a n d ne ur o m usc ular s yste m. 
Brief li mit e d p h ysical e x a mi nati o ns will be perf or me d at t h e ti mes i n dicate d i n t he Sc he d ule of 
Pr oce d ures ta ble i n A p p e n di x A. A li mite d p h ysi cal e x a mi nati o n will c o nsist of a mi ni m u m of 
ge n eral a p peara n ce, s ki n, heart, l u n gs, a n d a b d o m e n. 
All c o m plete a n d li mite d p h ysical e xa mi nati o n fi n di n gs m ust be rec or de d. 
8. 1 0  
Hei g ht a n d Wei g ht 
Hei g ht a n d wei g ht will be meas ure d at t he ti mes i n dicate d i n t he Sc he d ule of Pr oce d ures ta ble i n 
A p pe n di x A a n d will be use d t o calc ulate B MI. H ei g ht will be meas ure d wit h t he patie nt’s s h oes 
off. W ei g ht will be m eas ure d wit h t he p atie nt’s s h oes off a n d after t h e patie nt’s bla d der has b ee n 
e m ptie d. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
5 8  
9. 2. 1. 4  
P har mac o ki n etic a nal ysis 
T he CI N- 1 0 2 plas ma c o nce ntrati o ns a n d P K para meters will be liste d b y i n di vi d ual a n d 
s u m marize d b y treat m e nt f or acti ve treat m e nts i n ta b ular f or mat usi n g des cri pti ve statistics. 
CI N- 1 0 2 plas ma c o nce ntrati o ns will b e pl otte d a gai nst ti me p oi nts b y re gi me n ( mea n a n d 
i n di vi d ual). 
9. 2. 1. 5  
P har mac o ki n etic- P har mac o d y n a mic a n al ysis 
 If t he data per mit, a n atte m pt will be ma de t o c orrelate plas ma c o nce ntrati o n a n d/ or P K para meters 
wit h select safet y meas ures, pr olacti n data, a n d/ or meas ures of gastric e m pt yi n g ti me a n d 
s y m pt o ms of gastr o paresis. 
9. 2. 2  
A nal ysis of Safet y 
Safet y data, i n cl u di n g p h ysical e xa mi n ati o ns, E C Gs, vital si g n ass ess me nts, cli nical la b orat or y 
e val uati o ns (i ncl u di n g pr olacti n), a n d a d vers e e ve nts, will be s u m marize d b y treat me nt gr o u p a n d 
ti m e of c ollecti o n, w he n a p pr o priate. I n di vi d ual a n d mea n ti me c o urse of a bs ol ute pr olacti n v al ues 
a n d c ha n ge fr o m baseli ne pr olacti n b y treat m e nt ma y als o be ge nerate d. 
Descri pti ve statistics (arit h metic mea n, sta n dar d de viati o n, me dia n, mi ni m u m, a n d ma xi m u m) will 
be calc ulate d f or q u a ntitati ve safet y d ata, as w ell as f or t h e differe nce fr o m b aseli ne, w h e n 
a p pr o priate. A bs ol ute a n d c ha n ge fr o m baseli ne v al u es i n Q T ( usi n g Q Tc F) will be pl ott e d a gai nst 
ti m e p oi nts b y treat me nt, if a p pli ca ble. T h e ce ntral o verrea d E C G data will b e utilize d f or all s afet y 
assess me nts a n d a n al ys es. 
S hift ta bles descri bi n g o ut- of- n or mal ra n ge s hifts will be pr o vi de d f or cli ni cal la b orat or y res ults. 
9. 2. 3  
I nteri m A nal ysis 
A n i n de pe n de nt D R C will re vie w e mer gi n g s afet y, P K, a n d/ or efficac y data t hr o u g h o ut t he st u d y 
t o deter mi ne if it is safe a n d a p pr o priate t o c o nti n ue t he st u d y wit h t he c urre ntl y pl a n ne d d ose 
le vels f or C o h orts 2 a n d 3 or if f urt her refi ne me nt of t h e pr o p ose d d ose l e vels is warra nte d. T he 
D R C will als o deter mi ne h o w t o a d v a nce t he c o h orts. F urt her d etails re gar di n g t he r ole, 
res p o nsi bilities, a n d pr oce d ures of t h e D R C will be pr o vi de d i n t he D R C C h arter. 
9. 2. 4  
Sa m ple Size Deter mi nati o n 
A t otal of 6 0 patie nts ( 1 5 patie nts per treat m e nt) will be ra n d o miz e d t o CI N- 1 0 2  
 BI D, 
CI N- 1 0 2  
 BI D, CI N- 1 0 2  
 BI D, or pla ce b o. T he sa m ple size is c o nsi dere d a de q u ate t o 
pr o vi de t he n ecess ar y dat a t o e val uate t he o bjecti ves of t h e st u d y. N o f or mal statistical assess me nt 
f or s a m ple size deter mi n ati o n has bee n perf or me d.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
5 9  
1 0  
D A T A M A N A G E M E N T A N D R E C O R D K E E PI N G 
1 0. 1  
D at a M a n a ge me nt 
1 0. 1. 1  
Data Ha n dli n g 
Data will be rec or d e d at t he site o n e C R Fs a n d re vie we d b y t h e cli nical res earc h ass ociate ( C R A) 
d uri n g m o nit ori n g visits. T he C R As will verif y data rec or de d i n t h e E D C s yst e m wit h s o urce 
d oc u me nts. All c orrecti o ns or c ha n ges ma de t o a n y st u d y data m ust be a p pr o priatel y trac ke d i n a n 
a u dit trail i n t he E D C s yst e m. A n e C R F will be c o nsi dere d c o m plete w he n all missi n g, i nc orrect, 
a n d/ or i nc o nsiste nt data h as bee n a cc o u nte d f or. 
1 0. 1. 2  
C o m p uter S yst e ms 
Data will b e pr ocesse d usi n g a v ali date d c o m p uter s yste m c o nf or mi n g t o re g ulat or y re q uire me nts. 
1 0. 1. 3  
Data E ntr y 
Data m ust be rec or de d usi n g t h e E D C s yste m as t he st u d y is i n pr o gress. All sit e pers o n nel m ust 
l o g i nt o t he s yste m usi n g t h eir sec ure user na me a n d pass w or d i n or der t o e nter, re vie w, or c orrect 
st u d y data. T hese pr oce d ures m ust c o m pl y wit h Title 2 1 of t he C o de of Fe d eral Re g ulati o ns 
( 2 1 C F R P art 1 1) a n d ot her a p pr o priate i nter nati o nal re g ulati o ns. All pass w or ds will be strictl y 
c o nfi de ntial. 
1 0. 1. 4  
Me dical I nf or mati o n C o di n g 
F or me dical i nf or mati o n, t he f oll o wi n g t hesa uri will be use d: 
 Me dical Dicti o nar y f or R e g ul at or y Acti viti es (latest) f or me dical hist or y a n d a d v erse e ve nts 
 W orl d Healt h Or ga nizati o n Dr u g Dicti o nar y f or pri or a n d c o n c o mita nt me di cati o ns 
1 0. 1. 5  
Data Vali dati o n 
Vali dati o n c hec ks pr o gra m me d wit hi n t he E D C s yste m, as w ell as s u p ple me ntal vali dati o n 
perf or me d via re vie w of t h e d o w nl o a de d data, will be a p plie d t o t h e data i n or der t o e ns ure 
acc urate, c o nsiste nt, a n d reli a ble data. Dat a i d e ntifie d as err o ne o us, or data t hat are missi n g, will 
be referre d t o t he i n vesti gati ve site f or res ol uti o n t hr o u g h d ata q ueries. 
T he e C R Fs m ust be re vi e we d a n d electr o nicall y si g ne d b y t h e I n vesti gat or. 
1 0. 2  
Rec o r d Ke e pi n g 
Rec or ds of p atie nts, s o urce d oc u m e nts, m o nit ori n g visit l o gs, e C R Fs, i n ve nt or y of st u d y pr o d uct, 
re g ulat or y d oc u m e nts, a n d ot her S p o ns or c orres p o n de nce p ertai ni n g t o t h e st u d y m ust b e ke pt i n 
t he a p pr o priate st u d y files at t h e sit e. S o urce data is defi n e d as all i nf or mati o n i n ori gi n al rec or ds 
a n d certifie d c o pies of ori gi n al r ec or ds of cli nical fi n di n gs, o bser vati o ns, or ot her acti vities i n a 
cli nical st u d y necessar y f or t he e val uati o n a n d rec o nstr ucti o n of t he cli nical st u d y. S o urce d ata are 
c o ntai n e d i n s o urce d oc u me nts ( ori gi nal rec or ds or certifie d c o pi es). T h ese rec or ds will be retai ne d 
i n a sec ure file f or t he p eri o d as set f ort h i n t h e Cli nical St u d y A gree m e nt. Pri or t o tr a nsfer or 
destr ucti o n of t hese rec or ds, t he S p o ns or m ust b e n otifie d i n writi n g a n d be gi v e n t he o p p ort u nit y 
t o f urt her st ore s u c h rec or ds.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
6 0  
1 1  
I N V E S TI G A T O R R E Q UI R E M E N T S A N D Q U A LI T Y C O N T R O L  
1 1. 1  
Et hic al C o n d u ct of t he St u d y 
G o o d Cli nical Practice ( G C P) is a n i nter nati o n al et hical a n d s cie ntific q ualit y sta n dar d f or 
desi g ni n g, c o n d u cti n g, rec or di n g, a n d re p orti n g st u dies t hat i n v ol ve h u ma n patie nts. C o m plia nce 
wit h t his sta n dar d pr o vi d es p u blic ass ura nce t hat t he ri g hts, safet y, a n d w ell- bei n g of st u d y p atie nts 
are pr otecte d, c o nsiste nt wit h t h e pri nci ples t hat h a ve t heir ori gi n i n t he D eclarati o n of H elsi n ki, 
a n d t hat t he cli nical st u d y dat a are cre di ble. 
1 1. 2  
I nstit uti o n al Re vi e w B o ar d 
T he I nstit uti o nal Re vie w B oar d (I R B) will re vie w all a p pr o priate st u d y d o c u me ntati o n i n or der t o 
safe g uar d t he ri g hts, safet y, a n d w ell- bei n g of p atie nts. T he st u d y will o nl y be c o n d ucte d at sites 
w here I R B a p pr o v al has b ee n o btai ne d. T he pr ot oc ol, I n vesti gat or’s Br o c h ure, I C F, a d vertis e me nts 
(if a p pli ca ble), writt e n i nf or mati o n gi ve n t o t he p atie nts, safet y u p d ates, a n n ual pr o gress re p orts, 
a n d a n y re visi o ns t o t hes e d oc u me nts will be pr o vi de d t o t he I R B b y t h e I n vesti gat or. 
Fe deral re g ul ati o ns a n d I nter nati o nal C o u ncil f or Har m o nis ati o n (I C H) G ui deli n es re q uire t h at 
a p pr o v al be o btai ne d fr o m a n I R B pri or t o partici pati o n of patie nts i n researc h st u dies. Pri or t o 
st u d y o nset, t h e pr ot oc ol, a n y pr ot o c ol a me n d m e nts, I C Fs, a d v ertise me nts t o be us e d f or p atie nt 
recr uit m e nt, a n d a n y ot h er writte n i nf or mati o n re gar di n g t his st u d y t o be pr o vi de d t o a pati e nt or 
patie nt’s le gal g uar di a n m ust be a p pr o ve d b y t he I R B. 
N o dr u g will be release d t o t he site f or d osi n g u ntil writte n I R B a ut h orizati o n has bee n recei v e d 
b y t he S p o ns or. 
1 1. 3  
I nf or me d C o ns e nt 
T he I C F a n d a n y c ha n ges t o t h e I C F m a de d uri n g t he c o urse of t h e st u d y m ust be a gr ee d t o b y t h e 
S p o ns or or desi g nee a n d t he I R B pri or t o its use a n d m ust be i n c o m plia n ce wit h all I C H G C P, 
l ocal re g ulat or y re q uire me nts, a n d le gal re q uire me nts.  
T he I n vesti gat or m ust e ns ure t h at eac h st u d y p atie nt is f ull y i nf or me d a b o ut t h e nat ure a n d 
o bjecti ves of t he st u d y a n d p ossi ble ris ks ass ociate d wit h partici pati o n a n d m ust e ns ure t h at t h e 
patie nt has bee n i nf or m e d of his/ h er ri g hts t o pri vac y. T he I n vesti gat or will o btai n writt e n i nf or m e d 
c o nse nt fr o m eac h p atie nt bef ore a n y st u d y-s pecifi c acti vit y is p erf or me d a n d s h o ul d d oc u me nt i n 
t he s o urce d oc u me ntati o n t h at c o nse nt w as o btai n e d pri or t o e nr oll me nt i n t h e st u d y. T he ori gi n al 
si g ne d c o p y of t he I C F m ust be mai ntai ne d b y t he I n v esti gat or a n d is s u bject t o i ns p ecti o n b y a 
re pres e ntati ve of t h e S p o ns or, t heir re prese ntati ves, a u dit ors, t he I R B, a n d/ or re g ulat or y a ge n cies. 
A c o p y of t h e si g ne d I C F will be gi ve n t o t he p atie nt. 
1 1. 4  
St u d y M o nit ori n g Re q uire me nts 
It is t he res p o nsi bilit y of t he I n v esti gat or t o e ns ure t hat t he st u d y is c o n d uct e d i n acc or d a nce wit h 
t he pr ot oc ol, Declarati o n of H elsi n ki, I C H G C P, a n d a p plica ble re g ulat or y re q uire me nts, a n d t hat 
vali d data are e ntere d i nt o t he e C R Fs. 
T o ac hie ve t his o bjecti v e, t he C R A’s d uti es are t o ai d t h e I n vesti gat or a n d, at t he sa me ti me, t he 
S p o ns or i n t he mai nte na nce of c o m plete, l e gi ble, w ell- or ga niz e d a n d easil y retrie va ble d ata. Bef ore 
t he e nr oll me nt of a n y p atie nt i n t his st u d y, t he S p o ns or or t heir desi g nee will re vie w wit h t he 
I n v esti gat or a n d site p ers o n nel t h e f oll o wi n g d oc u me nts: pr ot o c ol, I n v esti gat or’s Br oc h ure, e C R Fs 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
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a n d pr oce d ures f or t h eir c o m pleti o n, i nf or me d c o nse nt pr ocess, a n d t h e pr oce d ure f or re p orti n g 
S A Es. 
T he I n v esti gat or will per mit t he S p o ns or or t heir desi g nee t o m o nit or t he st u d y as fre q ue ntl y as 
dee me d necessar y t o deter mi ne t hat data rec or di n g a n d pr ot o c ol a d here nce are satisfact or y. D uri n g 
t he m o nit ori n g visits, i nf or mati o n rec or de d o n t he e C R Fs will be v erifie d a gai nst s o urce 
d oc u me nts a n d re q uests f or clarificati o n or c orrecti o n ma y be m a de. After t he e C R F d ata is e ntere d 
b y t h e sit e, t h e C R A will re vie w t h e data f or safet y i nf or mati o n, c o m plete ness, acc urac y, a n d 
l o gical c o nsiste nc y. C o m p uter pr o gra ms t h at i d e ntif y data i nc o nsiste ncies ma y b e us e d t o h el p 
m o nit or t he cli nical st u d y. If n ecessar y, re q uests f or clarificati o n or c orrecti o n will be se nt t o t he 
I n v esti gat ors. T he I n vesti gat or a n d his/ her staff will be e x pecte d t o c o o perat e wit h t h e m o nit or a n d 
pr o vi de a n y missi n g i nf or mati o n, w he ne ver p ossi ble. 
All m o nit ori n g acti vities will be re p orte d a n d arc hi ve d. I n a d diti o n, m o nit ori n g visits will be 
d oc u me nte d at t h e i n vesti gati o nal sit e b y si g nat ure a n d date o n t h e st u d y-s pecific m o nit ori n g l o g. 
1 1. 5  
Discl os ure of D at a 
Data ge nerate d b y t his st u d y m ust be a vaila ble f or i ns pecti o n b y t he F D A, t he S p o ns or or t h eir 
desi g nee, a p plica ble f orei g n healt h a ut h oriti es, a n d t he I R B as a p pr o priate. Patie nts or t heir le gal 
re pres e ntati ves ma y re q u est t heir me di cal i nf or mati o n be gi ve n t o t h eir pers o nal p h ysicia n or ot h er 
a p pr o priate m e dical pers o n nel res p o nsi ble f or t heir welfare. 
Patie nt me dical i nf or mati o n o btai ne d d uri n g t he st u d y is c o nfi de ntial a n d discl os ure t o t hir d parties 
ot her t ha n t h ose n ote d a b o ve is pr o hi bite d. 
1 1. 6  
Rete nti o n of Rec or ds 
T o e na ble e val uati o ns a n d/ or a u dits fr o m re g ulat or y a ut h orities or t he S p o ns or, t he I n v esti gat or 
will k ee p rec or ds, i n cl u di n g t he i d e ntit y of all p arti ci pati n g p atie nts (s uffi cie nt i nf or mati o n t o li n k 
rec or ds; e g, e C R Fs a n d h os pital rec or ds), all ori gi n al si g ne d I C Fs, c o pies of all e C R Fs, S A E f or ms, 
s o urce d oc u me nts, a n d d etaile d rec or ds of treat m e nt dis p ositi o n. T he rec or ds s h o ul d be retai ne d 
b y t h e I n vesti g at or acc or di n g t o s pecificati o ns i n t he I C H g ui deli nes, l ocal re g ulati o ns, or as 
s pecifie d i n t h e Cli nical St u d y A gree me nt, w hi c he ver is l o n ger. T he I n v esti gat or m ust o btai n 
writte n per missi o n fr o m t he S p o ns or bef ore dis p osi n g of a n y rec or ds, e ve n if ret e nti o n 
re q uire me nts ha v e b ee n m et. 
If t h e I n vesti gat or rel o cat es, retires, or f or a n y reas o n wit h dra ws fr o m t he st u d y, t he S p o ns or s h o ul d 
be pr os pecti vel y n otifie d. T he st u d y rec or ds m ust be tra nsferre d t o a n a cce pta ble d esi g nee, s uc h 
as a n ot her I n v esti g at or, a n ot her i nstit uti o n, or t o t he S p o ns or.  
1 1. 7  
P u blic ati o n P olic y 
F oll o wi n g c o m pleti o n of t he st u d y, t h e data m a y be c o nsi dere d f or p u blicati o n i n a scie ntifi c 
j o ur nal or f or re p orti n g at a scie ntific meeti n g. Eac h I n vesti gat or is o bli gate d t o kee p data 
pertai ni n g t o t he st u d y c o nfi de ntial. T he I n v esti gat or m ust c o ns ult wit h t he S p o ns or bef ore a n y 
st u d y data are s u b mitt e d f or p u blicati o n. T he S p o ns or reser ves t h e ri g ht t o de n y p u blicati o n ri g hts 
u ntil m ut ual a gree me nt o n t he c o nte nt, f or mat, i nter pretati o n of data i n t he ma n uscri pt, a n d j o ur nal 
selecte d f or p u bli cati o n are ac hi e ve d. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
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1 1. 8  
Fi n a nci al Discl os ure 
I n v esti gat ors are re q uire d t o pr o vi de fi n a ncial discl os ure i nf or mati o n t o t h e S p o ns or t o per mit t he 
S p o ns or t o f ulfill its o bli gati o ns u n d er 2 1 C F R Part 5 4. I n a d diti o n, I n vesti gat ors m ust c o m mit t o 
pr o m ptl y u p dati n g t his i nf or mati o n if a n y rele va nt c ha n ges o cc ur d uri n g t he st u d y a n d f or a p eri o d 
of 1 year after t he c o m pl eti o n of t h e st u d y. 

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Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
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6 3  
1 2  
S T U D Y A D MI NI S T R A TI V E I N F O R M A TI O N 
1 2. 1  
Pr ot oc ol A me n d me nts 
A n y a me n d me nts t o t he st u d y pr ot o c ol will be c o m m u nicate d t o t he I n v esti gat ors b y  
 or 
t he S p o ns or. All pr ot oc ol a me n d me nts will u n der g o t he sa me re vi e w a n d a p pr o v al pr ocess as t he 
ori gi nal pr ot oc ol. A pr ot oc ol a me n d me nt ma y be i m ple me nte d after it has b ee n a p pr o ve d b y t h e 
I R B, u nless i m me diate i m ple me nt ati o n of t h e c ha n ge is necessar y f or patie nt safet y. I n t his case, 
t he sit uati o n m ust be d oc u me nte d a n d re p orte d t o t he I R B wit hi n 5 w or ki n g da ys. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
6 4  
1 3  
R E F E R E N C E S 
1.
Bielefel dt K. Gastr o p aresis: c o nce pts, c o ntr o versies, a n d c halle n ges. S cie ntific a ( C air o) .
2 0 1 2; 2 0 1 2: 4 2 4 8 0 2.
2.
Par k ma n H P, J ac o bs M R, Mis hra A, et al. D o m peri d o ne treat m e nt f or gastr o paresis:
de m o gra p hic a n d p h ar ma c o ge netic c haracterizati o n of cli nical efficac y a n d si de-effects.
Di g Dis Sci . 2 0 1 1; 5 6( 1): 1 1 5- 1 2 4.
3.
U S De part m e nt of H ealt h a n d H u ma n Ser vic es, F o o d a n d Dr u g A d mi nistrati o n, Ce nter
f or Dr u g E v al uati o n a n d Researc h ( C D E R). Gastr o paresis: cli nical e v al uati o n of dr u gs
f or treat m e nt. G ui d a nce f or i n d ustr y [ draft g ui da n ce]. J ul y 2 0 1 5.
4.
Ca mill eri M, B har u c ha A E, Farr u gia G. E pi d e mi ol o g y, mec ha nis ms, a n d m a na ge me nt of
dia beti c gastr o paresis. Cli n G astr oe nter ol He p at ol . 2 0 1 1; 9( 1): 5- 1 2.
5.
Ortiz A, C o o per CJ, Al v arez A, et al. Car di o vas c ular safet y pr ofile a n d cli nical
e x perie nce wit h hi g h- d os e d o m peri d o ne t h era p y f or na usea a n d v o miti n g. A m J Me d S ci .
2 0 1 5; 3 4 9( 5): 4 2 1- 4 2 4.
6.
7.
M otili u m ®  ( d o m peri d o ne) [ pr o d uct i nf or mati o n]. M ac q uari e Par k, N S W, A ustralia.
J a nsse n- Cil a g Pt y Lt d. 0 4 Fe br u ar y 2 0 1 9.
8.
Re d d y mas u S C, S o y k a n I, M c Call u m R W. D o m peri d o ne: re vi e w of p har m ac ol o g y a n d
cli nical a p plicati o ns i n gastr oe nter ol o g y. A m J G astr oe nter ol . 2 0 0 7; 1 0 2( 9): 2 0 3 6- 2 0 4 5.
9.
Ca mill eri M, Par k m a n H P, S hafi M A, et al. Cli nical g ui d eli n e: ma n a ge me nt of
gastr o p aresis. A m J G astr oe nt er ol . 2 0 1 3; 1 0 8( 1): 1 8- 3 7.
1 0. Fitz geral d P, Di na n T G. Pr olacti n a n d d o pa mi ne: w hat is t he c o n necti o n? A re vie w
article. J Ps yc h o p h ar m a c ol . 2 0 0 8; 2 2( 2 S u p pl): 1 2- 1 9.
1 1. B uffer y PJ, Str ot h er R M. D o m peri d o ne safet y: a mi ni-re vie w of t h e s cie nce of Q T
pr ol o n gati o n a n d cli nical i m plicati o ns of rece nt gl o bal re g ulat or y rec o m me n dati o ns.
N Z Me d J.  2 0 1 5; 1 2 8( 1 4 1 6): 6 6- 7 4.
1 2. E ur o pea n Me dici n es A ge nc y, P har mac o vi gila nce Ris k Assess me nt C o m mitt ee ( P R A C).
Assess me nt re p ort. D o m peri d o ne-c o ntai ni n g m e dici nal pr o d ucts. Marc h 2 0 1 4.
1 3. F D A Briefi n g D oc u m e nt ( D o m peri d o ne). P har mac y C o m p o u n di n g A d vis or y C o m mittee
Meeti n g. Oct o ber 2 0 1 5.
1 4. Bie we n ga J, Ke u n g C, S ola n ki B, et al. A bs e nce of Q Tc pr ol o n gati o n wit h d o m peri d o ne:
a ra n d o mize d, d o u ble ‐bli n d, place b o ‐ a n d p ositi ve‐c o ntr olle d t h or o u g h Q T/ Q Tc st u d y i n
healt h y v ol u nteers. Cli n P h ar m ac ol Dr u g Dev . 2 0 1 5; 4( 1): 4 1- 4 8.
1 5. U S De part m e nt of H ealt h a n d H u ma n Ser vic es, F o o d a n d Dr u g A d mi nistrati o n, Ce nter
f or Dr u g E v al uati o n a n d Researc h ( C D E R), Ce nter f or Bi ol o gics E v al uati o n a n d
Researc h ( C B E R). E 1 4 cli nical e val uati o n of Q T/ Q Tc i nter val pr ol o n gati o n a n d
pr oarr h yt h mic p ote ntial f or n o n-a nti arr h yt h mic dr u gs. G ui da n ce f or I n d ustr y.
Oct o ber 2 0 0 5.
1 6.
M otili u m ®  ( d o m peri d o ne) [ datas heet]. A uc kla n d, Ne w Zeala n d. J a nss e n- Cila g
( Ne w Zeala n d) Lt d. 0 2 Ma y 2 0 1 6.
1 7. F o o d a n d Dr u g A d mi nistrati o n, Ce nter f or Dr u g E v al uati o n a n d Researc h. P har mac y
C o m p o u n di n g A d vis or y C o m mitt ee ( P C A C) Meeti n g tra nscri pt. 2 8 Oct o ber 2 0 1 5.

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
6 5  
 
1 8.  B o yce MJ, Baisle y KJ, Warri n gt o n SJ. P har mac o ki neti c i nteracti o n bet w ee n 
d o m peri d o ne a n d ket o c o naz ole lea ds t o Q T pr ol o n gati o n i n healt h y v ol u nt eers: a 
ra n d o mize d, place b o-c o ntr olle d, d o u ble- bli n d, cr oss o ver st u d y. Br J Cli n P h ar m ac ol . 
2 0 1 2; 7 3( 3): 4 1 1- 4 2 1. 
1 9.  U S F o o d a n d Dr u g A d mi nistrati o n. H o w t o re q uest d o m peri d o ne f or e x pa n de d access 
use. 
htt ps:// w w w.f da. g o v/ dr u gs/ d e vel o p me nt a p pr o v al pr ocess/ h o w dr u gs are de v el o pe da n da p pr o
ve d/a p pr o vala p plicati o ns/i n vesti gati o nal ne w dr u gi n da p plicati o n/ uc m 3 6 8 7 3 6. ht m. 
Access e d 0 9 A u g ust 2 0 1 8. 
2 0.  B har u c ha A E, Ca milleri, M, Veil, E. C o m pre he nsi ve assess me nt of gastric e m pt yi n g wit h 
a sta ble is ot o pe breat h test. Ne ur o g astr oe nter ol M otil . 2 0 1 3; 2 5( 1). 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
Versi o n 2. 0, A me n d me nt 1, 1 5 A u g 2 0 1 9 
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A P P E N DI X B: C LI NI C A L L A B O R A T O R Y A N A L Y T E S 
St a n d ar d S afet y C he mistr y P a nel 
Ala ni ne a mi n otra nsferas e 
Al b u mi n 
Al kali ne p h os p hatase 
A m ylase 
As partate a mi n otra nsferase 
Bicar b o nate 
Bl o o d urea nitr o ge n 
Calci u m 
C hl ori de 
Creati n e ki n ase 
Creati ni ne 
Esti mate d gl o mer ular filtrati o n rate 
Ga m ma- gl uta m yl tra nsferas e 
Gl uc ose 
I n or ga nic p h os p h or us 
Lactate d e h y dr o ge n ase 
Li pas e 
P otassi u m 
S o di u m 
T otal bilir u bi n 
T otal pr otei n 
Uric aci d 
 
E n d ocri n ol o g y 
F olli cle-sti m ulati n g h or m o ne [ 1] 
T h yr oi d-sti m ulati n g h or m o ne 
Pr olacti n 
1. F olli cle-sti m ulati n g h or m o ne will o nl y be assess e d i n fe m ales w h o h a ve bee n 
p ost me n o pa usal f or at le ast 1 year a n d are n ot s ur gicall y sterile. 
 
He m at ol o g y 
He mat ocrit 
He m o gl o bi n 
Platelets 
R e d bl o o d cell c o u nt 
Gl yc os yl ate d he m o gl o bi n 
 
W hite bl o o d cell c o u nt a n d differe ntial [ 1]  
 
1. Ma n ual micr osc o pic re vie w is perf or m e d o nl y if w hite bl o o d cell c o u nt a n d/ or 
differe ntial v al ues are o ut of refere n ce ra n ge. 
 
Uri n al ysis 
Bilir u bi n 
Bl o o d 
Gl uc ose 
Ket o nes 
Le u k o c yte est eras e 
Micr osc o p y [ 1] 
Nitrite 
p H 
Pr otei n 
S p ecific gra vit y 
Ur o bili n o ge n 
 
1. Micr osc o p y is perf or m e d o nl y as nee d e d base d o n p ositi ve di psti c k res ults. 
 

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Cli nical St u d y Pr ot oc ol CI N- 1 0 2- 1 2 1 
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Ser ol o g y 
He patitis B s urface a nti ge n  
He patitis C vir us a nti b o d y 
H u ma n i m m u n o deficie nc y vir us a nti b o d y  
 
 
Pre g n a nc y Test 
Ser u m a n d p oi nt- of-care pre g na nc y tests will o nl y be perf or me d i n fe males w h o are n ot 
s ur gicall y sterile ( or p ost me n o pausal f or at least 1 year [ wit h  c o nfir me d F S H i n p ost me n o pa usal 
ra n ge at t he Scree ni n g Visit]). 
 
Uri ne Dr u g Scree n [ 1] 
A m p heta mi nes 
C ocai ne 
C oti ni ne 
O piates 
P he nc ycli di ne 
Tetra h y dr oca n na bi n ol 
1. Uri ne dr u g scree n p oi nt of car e dr u g test o n ra n d o mizati o n da y.  
 
Bre at h Alc o h ol Test 
 
 

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Cli nical St u d y Pr ot o c ol CI N- 1 0 2- 1 2 1 
C o nfi d e ntial & Pr o prietar y 
 
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A P P E N DI X C: E L E C T R O C A R DI O G R A M A L E R T C RI T E RI A 
G UI D A N C E 
I n v esti g at ors s h o ul d c o nt act t he S p o ns or o r desi g nee if a n y cli ni c all y me a ni n gf ul c h a n g es 
fr o m b aseli ne E C Gs, i n cl u di n g b ut n ot li mite d t o t h ose liste d bel o w, are n ote d u p o n re vi e w. 
 Q Tc F ≥4 5 0 msec ( male) 
 Q Tc F ≥4 7 0 msec (fe male) 
 A > 6 0 msec i ncreas e i n Q Tc F fr o m baseli n e 
 A 6 % or greater i n crease i n Q Tc F fr o m baseli ne 
Ne w o nset fi n di n gs i ncl u di n g b ut n ot li mite d t o t he f oll o wi n g: 
 Sec o n d de gree A V bl o c k ( M o bitz II) 
 T hir d de gree A V bl oc k ( c o m plete heart bl oc k) 
 Ac ut e m y o car dial i nfar cti o n 
 Ne w left b u n dle bra n c h bl o c k ( L B B B) 
 Se vere bra d ycar dia ( v e ntric ular rate ≤4 0 b p m) 
 S u pra ve ntric ular t ac h ycar dia ( S V T) ( v e ntric ul ar rate ≥1 5 0 b p m) 
 T orsa des de p oi ntes 
 Ve ntric ular t ac h yc ar dia ( T hree or m ore beats re gar dless of rate) 
 Ve ntric ular fi brillati o n 
 Atrial fi brill ati o n/atrial fl utt er ( ve ntric ul ar rat e ≥1 5 0 b p m)