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 ac e 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 ar 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 vesti 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 me P har ma, I nc. 
5 3 7 5 Me d pace Wa y  
Ci nci n nati, O H 4 5 2 2 7  
U nite d States  
 
 
 
 
Versi o n N u m ber:  1. 0  
D ate : 1 9  M a y  2 0 1 9  
 
 
 
 
C o nfi de 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 be discl ose 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 uir e d b y la w 
a n d f or t he p ur p ose of e v al uat i n g a n d/ or c o n d ucti 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 be i nf or me d t hat t he 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 parties.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
3  
I NV 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 hat: 
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 oc 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 nate 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 me P har ma, I n c. t o st u d y pers o n nel u n der m y s u p ervisi o n. I will disc uss t his material 
wit h t he m t o e ns ur e t he y are f ull y i nf or m e d a b o ut t he st u d y pr o d uct a n d st u d y pr oce d ures. I will 
let t he m k n o w t hat 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 parties. I u n d ersta n d t hat t he st u d y ma 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 me b y Ci n D o me P har ma, I nc., wit h or wit h o ut ca use, or b y me if 
it bec o mes necessar y t o pr otect t he best i nterests of t he st u d y p atie nt s. 
I a gree t o c o n d uct t his st u d y i n f ull acc or da n ce 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 
Co u ncil f or 
Har m o nisati o n G ui deli nes f or G o o d Cli nical Practices.  
 
 
 
 
 
 
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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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 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 Sa fet y, 
Efficac y, P har m ac o ki netics, a n d D ose R es p o nse of Oral CI N -1 0 2 i n A d ults wit h Dia beti c 
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 me 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 ve s 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 gastri c 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 he p h ar mac o ki netic ( 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  
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 usea sc ore o n  t he A meri ca n Ne ur o ga str 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 D ail y D i 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 ul ti ple d oses of CI N-1 0 2 o n a variet y of patie 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  years ol d wit h T y pe 1 or T y pe 2 
i ns uli n-de pe n de nt dia bet es mellit us , acc or di n g t o t he A merica n Dia b etes Ass ociati o n criteria, a n d 
a dia g n osis of dia betic gastr o p aresis d efi ne d b y u p per gastr oi ntesti nal s y m pt o ms felt t o be 
c o nsiste nt wit h gastr o p aresis a n d pre vi o usl y d oc u me nte d dela 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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
5  
S T U D Y D E SI G N A N D D U R A TI O N:  
T his is a ra n d o mize d, d o u ble -bli n d, place b o -c o ntr olle d P hase 2 A  st u d y t o e val uate  t he safet y, 
effic ac y, P K, a n d d o s e res p o nse of  oral  CI N -1 0 2 i n a d ults wit h dia betic gastr o paresis.  
T he st u d y will be gi n b y ra n d o mizi n g patie nts i n C o h ort 1 t o eit her CI N-1 0 2  
 t wice dail y 
( BI D) or pl ace b o BI D i n a  rati o s uc h t hat 1 5 p atie nts recei ve CI N-1 0 2 a n d 5 patie nts recei v e 
place b o. After C o h ort 1 c o m pletes t he st u d y, a Data Re vie w C o m mittee ( D R C) will c o n ve ne t o 
re vie w t he data fr o m C o h ort 1. 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 t h e 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 hese pla n ne d d ose le vels ma y be m o difie 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 wit h o ut a pr ot oc ol a me n d me nt. T he s u bse q ue nt c o h orts ( C o h orts 2 a n d 3 ) ma y 
be e nr olle d se q u e ntiall y or si m ulta ne o usl y . 
At t he Scree ni n g Visit, all patie nts will si g n i nf or me d c o nse nt pri or t o a n y s t u d y pr oce d ures bei ng 
perf or me d . Patie nts m ust meet all of t he i ncl usi o n criteria a n d n o ne of t he e x cl usi o n criteria t o be 
eli gi ble f or st u d y p artici p ati o n.  
Patie nts will be e val uate d as f oll o ws:  
 Da ys -2 8 t o -8 : Scree ni n g pr oce d ures will be p erf or me d. 
 
 
 
  
  
  
  
 
 
 
 Da y s -7  t o -2 : T he A N M S G C SI -D D  a n d P A GI -S Y M q uesti o n naire will b e c o m plete d dail y. 
A G E B T will be p erf or me d o n a si n gle da y wit hi n t his wi n d o w wit h breat h sa m ples 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 h e 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 aft er meal c o ns u m pti o n aft er a 6 -h o ur fast .  
 Da ys 1 t o 1 4 : St u d y dr u g will be a d mi nistere d ( CI N-1 0 2 or place b o BI D f or 1 4 [± 2] da ys) a n d 
safet y assess me nts will be perf or me d ; 
 
 P K bl o o d sa m plin g will be c o m plete d  at s pecifie d ti me p oi nts . 
N ote: Da y 1 4 ( ± 2 da ys): A G E B T will be a d mi nistere 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) . Breat h sa m ples will be o btai ne d t wice pri or t o 1 3C -e nric he d meal 
c o ns u m pti o n 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 
6 -h o ur fast . If a p atie nt wit h dra ws fr o m t he st u d y pri or t o t he Da y 1 4 (± 2  da ys) G E B T, atte m pts 
s h o ul d be ma de t o perf or m a G E B T o n t he last da y of st u d y dr u g  a d mi nistrati o n. 
 
 
O n da ys of t he G E B T, p atie nts will prese nt at t he cli nic after a n o ver ni g ht fast a n d s h o ul d ta ke 
re g ular m e dicati o ns, i ncl u di n g a n y treat me nt f or dia betes, wit h t he e x ce pti o n of a n y pr ohi bite d 
c o nc o mita nt me dicati o n. Patie nts will self -a d mi nister t heir us ual m or ni n g i ns uli n i njecti o n, ta ki n g 
i nt o c o nsi derati o n t heir fasti n g stat us. Patie nts will be i nstr ucte d t o bri n g i n t heir st u d y me dicati o n 
a n d a d diti o nal i ns uli n, as nee de d, t o t h e cl i nic. Fasti n g bl o o d gl uc os e will be assesse d bef 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 m e nts t o e ns ure a bl o o d gl uc ose of 2 7 5 m g/ d L. 
A d diti o nal i ns uli n ma y b e gi ve n ( pr orate d bas e d o n meal cal oric c o nte nt) t o e ns ure a bl o o d gl uc os e 
of 2 7 5 m g/ d L pri or t o t he gastric e m pt yi n g pr oce d ure. Li ke wise, I n vesti gat ors s h o ul d ma na ge 
l o w bl o o d s u gar ( h y p o gl yce mia; < 6 0 m g/ d L) as p er t heir discreti o n.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
6  
Safet y will be e val uat e d t hr o u g h ass ess me nts of a d verse e ve nts, vital si g ns, p h ysical e x a mi nati o ns, 
cli nical la b orat or y e v al uati o ns  (i ncl u di n g pr olacti n), a n d electr o car di o gra m ( E C G ) fi n di n gs. 
A d diti o nall y, a si n gle, o pti o nal p har mac o ge n o mic bl o o d sa m ple ma y be c ollecte d at a n y ti m e 
d uri n g t he p atie nt’s parti ci pati o n i n t he st u d y.  
Patie nts will ha ve a fi nal f oll o w -u p visit 2 t o 3 d a ys after t he fi nal d ose of st u d y dr u g t o assess 
a d verse e ve nts, c ha n ges t o c o nc o mita nt me dicati o ns (i ncl u di n g use of res c ue me dicati o ns), vital 
si g ns, a n d f or P K sa m pli n g. U nsc he d ule d visits a n d/ or a d diti o nal f oll o w-u p ma y be r e q uir e d at t h e 
discreti o n of t he I n vesti gat or. F or e x a m ple, patie nts wit h cli nicall y si g nifica nt a b n or mal la b orat or y 
fi n di n gs, u nres ol ve d treat me nt-e mer ge nt a d verse e ve nts, seri o us a d verse e ve nts t hat re q uire 
f oll o w-u p la b orat ori es a n d re vie w, or  cli nicall y si g nifica nt a d verse e v e nts ma y n ecessitate f urt her 
assess me nts.   
A st u d y sc h e matic is pres e nte d bel o w . 
St u d y Sc he m atic  
 
* F or eac h co h ort, patie nts will be ra n d o mize d t o CI N -1 0 2 or place b o. Ra n d o mizati o n ma y oc c ur o n Da y 1 or at a se parate visit 
o n Da y -1.  
BI D = 2 ti mes  dail y; D R C = D ata Re vie w C o m mittee; G E B T = gastric e m pt yi n g breat h test . 
D O S A G E F O R M S A N D R O U T E O F A D MI NI S T R A TI 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 after t he m or ni n g 
d ose o n t he da ys w he n t he G E B T a n d serial P K dra ws will be perf or me d (Da ys 1  a n d 
1 4  [± 2  da ys] ). 
 
E F FI C A C Y V A RI A B L E S:  
T he pri mar y effic ac y var ia ble is t he c ha n ge fr o m baseli ne ( gat here d o n Da ys -7 t o -2) i n gastri c 
e m pt yi n g as me as 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 oa cti ve sta 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 ne t he rate of gastric e m pt yi n g after c o ns u m pti o n of a sta n dar dize d, 1 3C -e nric he d 
meal. Patie nts will c o ns u me a sta n dar dize d, 
1 3C -e nric h e d meal after a 6 -h o ur fast at baseli n e 
( Da ys -7  t o -2 ) a n d aft er a 6-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 da ys) . Breat h sa m ples will be 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, 
S e q u e nti al or P ar all el 
E nr oll m e nt
Scr e e ni ng
D a ys -2 8 t o -8
B as eli n e G E B T
D a ys -7 t o -2
C o h ort 1
CI N -1 0 2  
 BI D
Pl ac e b o BI D *
C o h ort 2
CI N -1 0 2  
 BI D
Pl ac e b o BI D *
D R C R e vi e w
C o h ort 3
CI N -1 0 2  
 BI D
Pl ac e b o BI D *
F oll o w -u p
2 -3 d a ys aft er 
t h e l ast d os e
D o u bl e -bli n d tr e at m e nt 
p eri o d
BI D d osi ng fr o m t h e m or ni ng of 
D a y 1 t hr o ug h t h e m or ni ng of 
D a y 1 4 ( +/ - 2 d a ys)

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
7  
1 3C -e nric he d meal 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 6-h o ur fast o n Da ys -7 t o -2  a n d Da y 1 4 ( ± 2 d a 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).  
T he sec o n d ar y efficac y v aria bles are t he f oll o wi n g:  
 T he c ha n ge fr o m bas eli ne i n gastric e m pt yi n g ter mi nal p hase eli mi nati o n half-life (T ½ ) as 
meas ure d b y G E B T at D a y 1 4  ( ± 2 da ys) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
  
 
 
 
 
 
 
 
  
 
 
  
  
  
  
 
  
  
  
 
 
  
 
 
 
 
 
 
 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
9  
T he CI N -1 0 2 plas ma c o nc e 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 tr eat me nt f or acti ve treat me nts i n ta b ular f or mat usi n g descri pti ve statistics.  
CI N -1 0 2 plas ma c o nce ntrati o ns will be 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). 
A n atte m pt ma y b e ma de t o c haracterize e x p os ure -res p o ns e relati o ns hi ps f or meas ures of safet y 
a n d/ or effi cac y.  
Safet y d ata, i ncl u di n g p h ysical e x a mi nati o ns, E C Gs, vital si g n assess 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 verse e v e nts, will be s u m marize d b y treat me nt gr o u p a n d 
ti me 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 val ues 
a n d c ha n ge fr o m bas eli ne pr olacti n b y treat me 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 ua ntitati ve safet y data, as well as f or t he differe n ce fr o m b aseli ne, w he n 
a p pr o priate. A bs ol ute a n d c ha n ge fr o m baseli ne val ues i n Q T ( heart rate -c orrecte d Q T i nter val s 
usi n g Fri d ericia’s a n d Bazett’s f or m ulas) will be pl otte d a gai nst ti me p oi nts b y treat me nt, if 
a p plica ble.  
S hift ta bles descri bi n g o ut -of -n or mal r a n ge s hifts will be pr o vi de d f or cli ni cal la b orat or y res ults.  
Safet y, P K, a n d/ or effic ac y d ata will be re vie we d b y a n i n de pe n de nt D R C  w hile t he st u d y is 
o n g oi n g.  
S A M P L E SI Z E D E T E R MI N A TI O N:  
A t otal of 
a p pr o xi matel y 6 0 patie nts ( 1 5 p atie nts per gr o u p) will be 
ra n d omize 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 place b o. T he sa m ple siz e is 
c o nsi dere d a d e q uate t o pr o vi de t he necessar y d ata t o e val uate t he o bjecti ves of t he st u d y. N o 
f or mal statistical assess m e nt f or sa m ple siz e deter mi nati o n has bee n perf or me d. 
SI T E S:   U p t o 1 5  sites i n t he U nite d States 
S P O N S O R:  
Ci n D o me P har ma, I nc. 
5 3 7 5 Me d pace Wa y  
Ci nci n nati, O H 4 5 2 2 7  
U nite d States  
 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
1 0  
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 0  
List of Ta bl es  ................................................................................................................................ 1 4  
List of Fi g ures  ............................................................................................................................... 1 5  
List of A b bre viati o ns a n d Defi niti o n of Ter ms ............................................................................. 1 6  
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 8  
1. 1  
I n dic ati o n a n d Treat me nt O pti o ns ................................................................................. 1 8  
1. 2  
CI N -1 0 2  ......................................................................................................................... 1 9  
1. 3  
St u d y R ati o nale  ............................................................................................................. 2 0  
1. 4  
Ris k/ Be nefit  ................................................................................................................... 2 0  
2  St u d y O bjecti ves  ..................................................................................................................... 2 2  
2. 1  
O bjecti ves  ...................................................................................................................... 2 2  
2. 2  
E x pl orat or y O bjecti ves  .................................................................................................. 2 2  
3  St u d y Descri pti o n .................................................................................................................... 2 3  
3. 1  
S u m mar y of St u d y Desi g n  ............................................................................................ 2 3  
3. 2  
St u d y I n dicati o n  ............................................................................................................ 2 4  
4  Selecti o n a n d Wi t h dra wal of Patie nts ..................................................................................... 2 5  
4. 1  
I n cl usi o n Criteria ........................................................................................................... 2 5  
4. 2  
E x cl usi o n Criteria  .......................................................................................................... 2 6  
4. 3  
Ra n d o mizati o n Criteria  ................................................................................................. 2 8  
4. 4  
Wit h dra wal Criteria  ....................................................................................................... 2 9  
5  St u d y Treat me nts  .................................................................................................................... 3 0  
5. 1  
Treat me nt Gr o u ps  .......................................................................................................... 3 0  
5. 2  
Rati o nale f or D osi n g  ..................................................................................................... 3 0  
5. 3  
Ra n d o mizati o n a n d Bli n di n g  ......................................................................................... 3 0  
5. 4  
Brea ki n g t he Bli n d  ........................................................................................................ 3 1  

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

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
1 2  
7  Efficac y Assess me nts .............................................................................................................. 4 3  
7. 1  
Pri mar y Efficac y Assess me nt  ........................................................................................ 4 3  
7. 2  
Sec o n dar y Efficac y Assess me nt  .................................................................................... 4 3  
7. 3  
E x pl orat or y Effi cac y Assess me nt  ................................................................................. 4 3  
7. 4  
P har mac o ki netics  .......................................................................................................... 4 4  
7. 5  
P har mac o ge n o mic Ass ess me nts  .................................................................................... 4 5  
7. 5. 1  C ollecti 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 5  
8  Safet y Assess me nts  ................................................................................................................. 4 6  
8. 1  
A d verse E v e nts  .............................................................................................................. 4 6  
8. 1. 1  A d verse ( Dr u g) Reacti o n  .................................................................................. 4 7  
8. 1. 2  U ne x pecte d A d verse Dr u g Reacti o n  ................................................................. 4 7  
8. 1. 3  Assess me nt of A d verse E ve nts b y t he I n vesti gat or  .......................................... 4 7  
8. 2  
Seri o us A d verse E v e nts  ................................................................................................. 4 8  
8. 3  
Seri o us A d verse E v e nt Re p orti n g − Pr oce d ures f or I n vesti gat ors  ................................ 4 9  
8. 4  
Pre g n a nc y Re p orti n g  ..................................................................................................... 4 9  
8. 5  
E x pe dite d Re p orti n g  ...................................................................................................... 5 0  
8. 6  
Cli nical La b orat or y E val uati o ns  .................................................................................... 5 0  
8. 7  
Vital Si g ns  ..................................................................................................................... 5 1  
8. 8  
Electr ocar di o gra ms  ........................................................................................................ 5 1  
8. 9  
P h ysical E x a mi nati o ns  .................................................................................................. 5 1  
8. 1 0  Hei g ht a n d Wei g ht  ........................................................................................................ 5 2  
9  Statistics  .................................................................................................................................. 5 3  
9. 1  
A nal ysis P o p ulati o ns  ..................................................................................................... 5 3  
9. 2  
Statistical Met h o ds  ........................................................................................................ 5 3  
9. 2. 1  A nal ysis of Effic ac y  .......................................................................................... 5 3  
9. 2. 1. 1  Pri mar y efficac y a nal ysis  .................................................................... 5 3  
9. 2. 1. 2  Sec o n dar y efficac y a n al ysis  ................................................................ 5 3  
9. 2. 1. 3  E x pl orat or y efficac y a nal ysis  .............................................................. 5 3  
9. 2. 1. 4  Ot her efficac y a nal ys es  ....................................................................... 5 3  
9. 2. 1. 5  P har mac o ki netic a n al ysis  .................................................................... 5 4  
9. 2. 1. 6  P har mac o ki netic -P har mac o d y n a mic a n al ysis  ..................................... 5 4  

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

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
1 4  
LI S T O F T A B L E S  
Ta ble 1.  
Sc he d ule of Pr oce d ures  ............................................................................................... 6 2  
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
1 5  
LI S T O F F I G U R E S 
Fi g ure 1.  St u d y Sc h e matic .......................................................................................................... 2 4  
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
1 6  
L I 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 U C  
Area u n d er t he plas ma c o nce ntrati o n -ti me c ur ve 
BI D  
T wice dail y  
B MI  
B o d y mass i n de x  
C ma x  
Ma xi m u m plas ma c o nce ntrati o n  
C F R  
C o de of Fe d eral Re g ul ati o ns  
C N S  
Ce ntral ner v o us s yste m  
 
 
C R A  
C li nical R esearc h A ss o ciate 
C Y P  
C yt o c hr o me P 4 5 0  
D G E  
Dela ye d gastric 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 
E lectr o nic case re p ort f or m 
E D C  
Electr o nic data ca pt ur 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 Practice  
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 me 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 nisati o n 
I R B 
I nstit uti o nal Re vie w B oar d 
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 
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  
 
 
 
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 o n o m y  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
1 7  
A b bre viati o n  
Defi niti o n  
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  
Q Tc B  
H eart rate-c orrecte d Q T i nter val usi n g Bazett ’s f or m ula 
Q Tc F  
H eart 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  
 
 
T ½  
Ter mi nal 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 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
1 8  
1  
IN 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 Tre at me nt O pti o ns 
Gastr o paresis is defi ne d as i m paire 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 dis ease is ofte n ass ociate d wit h dia betes or ma y occ ur after gastric s ur ger y; 
it ma 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 peciall y i n dia beti cs, a n d se vere s y m pt o ms of gastr o p aresis ca n lea 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 ne treat me nt f or gastr o paresis i n v ol ves 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 pla ce me nt. P har 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 me. C urre ntl y, met ocl o pr a mi de, a d o pa mi ne 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 he 
treat me nt of gastr op aresis. 
W hile 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 ncl u de restless ness, dr o wsi ness, fat i g ue, a n d 
lassit u de; h o we ver, t h e maj or safet y c o ncer n wit h met ocl o pra mi de tr eat m e nt is t he de vel o p me nt 
of tar di ve 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 versi ble. I n crease d ris k of de v el o pi n g tar di ve 
d ys ki nesia c orrel ates t o treat me nt d urati o n; t heref ore, it is rec o m me n d e d t hat t hera p y wi t h 
met ocl o pra mi de n ot e x cee d 1 2  wee ks .6  
D o m peri d o ne is a p eri p heral d o p a mi ne 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 mac 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 me 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  da 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 patie nts i n t he 
U nite d 
States t hr o u g h 
a p h ysici a n -i nitiate d I n v esti gati o nal Ne w Dr u g a p plicati o n at d oses u p t o 1 2 0 m g/ da y ( 3 0 m g 
a d mi nistere d oral l 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 me n d t h e use of d o m p eri d o n e 
f or patie nts u na ble t o use met ocl o pra mi de.9  
U nli ke met ocl o pra mi de, d o m peri d o ne d oes n ot cr oss t he bl o o d -brai n barrier a n d sel d o m ca uses 
e xtra p yra mi dal si de 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 he 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 bility of d o m peri d o ne 
(a p pr o xi matel y 1 3 % t o 1 7 % of t he a d mi nistere d d ose), 8 oral d oses i n e x cess 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 niste re d t o patie nts at t he ti me w he n t he car di ac iss ues were 
re p orte d.1 1 W he 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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
1 9  
pre di s 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 me 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 . Ho 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 a m o n g patie nts ta ki n g d o m peri d o ne wit h n o ne of  these 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 he 
defi niti o n of Q T pr ol o n gati o n) ma y o cc ur w he n t he d o m peri 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 ( C ma x ) of 
d o m peri d o ne t o a p pr o xi matel y 6 0 n g/ m L ma y si g nifica ntl y l o w er t he ris k of Q T pr ol o n gati o n.  
1. 2  
CI N -1 0 2  
Ci n D o me P har ma, I nc. is c urre ntl y de v el 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 de 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 ve n t hat t he 
p har mac ol o gic al 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 less 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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
2 0  
1. 3  
St u d y R ati o n ale  
T o date, t he  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 v al 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 in p atie nts wit h gastr o p aresis. As s uc h, t his st u d y i s inte 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 oses . 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 patie nts will als o be 
assesse 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 ur e st u dies.  
1. 4  
Ris k/ Be nefit  
Si de effects t hat ha v e bee 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 hea, ras h, pr urit us, g y nec o mastia, breast te n der ness, 
gal act orr h ea, a me n orr hea, breast p ai n, irre g ular m e n str uati o n, lactati o n dis or ders, a n d ast he 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 tr eate d patie nts i ncl u de 
h y perse nsiti vi t 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 actic 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 ret e nti o n, a b n or mal li ver tests,  a n d i ncrease 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 veilla 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, ele ctr 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 ha 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 vie w of t he literat 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 p ect 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 dicate t hat t he 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 peri d o n e. 1 1 ,1 4 ,1 8 A d diti o nall y, t he 
F D A E x pa n de 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 peri 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 v e 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 d e d ness, as well as te m p orar y 
disc o mf or t, re d ness, or ras h at t he site of E C G electr o de place me nt, a n d dizzi ness, hea dac he, 
st o mac h disc o mf ort, or fai nti n g d ue t o f asti 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 safet y, t olera bilit y, a n d 
P K pr ofile esta blis he d i n t he P hase 1 S A D  a n d M A D  st u dies. T hes e d oses were well-t olerate d i n 
healt h y s u bjects. Gi ve n t he ass ociati o n of Q T pr ol o n gati o n a n d d o m peri d o n e, patie 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 verse e ve nts, i ncl u di n g t h ose t h at ha ve bee n re p orte d 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
2 1  
wit h d o m peri d o ne , a n d 1 2 -lea d E C Gs will be c ollecte d at eac h visit t o t he cli nic ( wit h t he e x ce pti o n 
of Da y 7 [ ± 1 da y]) .  
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 nt s wit h dia betic 
gastr o p aresis. Gi ve n t h e k n o w n a ntie 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 ve me nt i n t heir s y m pt o ms d uri n g t h e c o urse of t h is st u d y. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
2 2  
2  
S T U D Y O B J E C TI V E S  
2. 1  
O bjecti ves  
T he o bjecti ve s 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 he  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 na 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 he A merica n Ne 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 eff ect 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 o f m ulti ple d oses of CI N-1 0 2 o n a variet y of patie 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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
2 3  
3  
S T U D Y D E S C RI P TI O N  
3. 1  
S u m m ar y of St u d y Desi g n  
T his is a ra n d o mize d, d o u ble -bli n d, place b o -c o ntr olle d P hase 2 A  st u d y t o e val uate safet y, efficac y, 
P K, a n d d os e res p o nse of oral CI N-1 0 2 i n a d ults wit h dia betic gastr o paresis.  
T he st u d y will be gi n b y  ra n d o mizi n g patie 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 i n a rati o s u c h t hat 1 5 patie nts recei v e CI N -1 0 2 a n d 5 patie nts recei ve place b o. After 
C o h ort  1 c o m pletes t he st u d y, a Data Re vie w C o m mittee ( D R C) will c o n ve ne t o re vie w t h e data 
fr o m C o h ort 1. 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 t he 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 hese pl a n ne d d ose le vels ma y be m o difie d base d o n e m er 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 her o n g oi n g st u dies. T he hi g hest d os e will n ot e x cee d  
 BI D 
wit h o ut a pr ot oc ol a me n d me nt. T he s u bse q ue nt c o h orts ( C o h orts 2 a n d 3 ) ma y be e nr olle d 
se q ue ntiall y or si m ulta ne o usl y. 
At t he Scree n i n g Visit, all patie nts will si g n i nf or me d c o nse nt pri or t o a n y st u d y pr oce d ures b ei n g 
perf or me d. Patie nts m ust meet all of t he i ncl usi o n criteria a n d n o n e of t he e x cl usi o n criteria t o be 
eli gi ble f or st u d y p artici p ati o n.  
Patie nts will be e val uate d as f ol l o ws: 
 Da ys -2 8 t o -8 : Scree ni n g pr oce d ures will be perf or me d. 
 
  
 
  
  
  
  
 
 
 
 Da y -7  t o -2 : T he A N M S G C SI -D D  a n d P A GI -S Y M  q uesti o n naire  will be c o m plete d dail y . A 
G E B T  will be perf or me d o n a si n gle da y wit hi n t his wi n d o w wit h breat h sa m ples o btai ne d 
t wice pri or t o c o ns u m pti o n  of a sta n d ar dize d, 1 3C -e nric h e d meal a n d t he n at 4 5, 9 0, 1 2 0, 15 0, 
1 8 0 , a n d 2 4 0 mi n utes aft er meal c o ns u m pti o n aft er a 6 -h o ur fast .  
 Da ys 1 t o 1 4 : St u d y dr u g will be a d mi nistere d ( CI N-1 0 2 or place b o BI D  f or 1 4 [± 2] da ys ) a n d 
safet y assess me nts will be perf or me d ; 
 
 P K bl o o d sa m pli n g will be c o m plete d  at s pecifie d ti me p oi nts . 
N ote: Da y 1 4 ( ± 2 da ys): A G E B T will b e a d mi nistere 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). Breat h sa m ples will be o btai ne d t wice pri or t o 
1 3C e nric he d meal 
c o ns u m pti o n 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 aft er a 
6 -h o ur fast. If a patie nt wit h dra ws fr o m t he st u d y pri or t o t he Da y 1 4 ( ± 2 da ys) G E B T, atte m pts 
s h o ul d be ma de t o perf or m a G E B T o n t he last da y of st u d y dr u g a d mi nistrati o n. 
 
 
O n da ys of t he G E B T , p atie nts will prese nt at t he cli nic after a n o v er ni g ht fast a n d s h o ul d ta ke 
re g ular me dicati o ns, i ncl u di n g a n y treat me nt for dia betes,  wit h t he e x ce pti o n of a n y pr o hi bite d 
c o nc o mita nt me dicati o n. Patie nts will self -a d mi nister t heir us ual m or ni n g i ns uli n i njecti o n, ta ki n g 
i nt o c o nsi derati o n t heir fasti n g stat us. Patie nts will  be i nstr ucte d t o bri n g i n t heir st u d y m e dicati o n  
a nd a d diti o nal i ns uli n, as nee de d, t o t he cli nic . Fasti n g bl o o d gl uc ose will be assesse d bef 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 uc ose of 2 7 5 m g/ d L. 
A d diti o nal i ns uli n ma y b e gi ve n  ( pr orate d b ase d o n meal cal oric c o nte nt)  t o e ns ure a bl o o d gl uc ose 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
2 4  
of 2 7 5 m g/ d L pri or t o t he gastric e m pt yi n g pr oce d ure.  Li ke wise, I n vesti gat ors s h o ul d ma na ge 
l o w bl o o d s u gar ( h y p o gl yce mia; < 6 0  m g/ d L) as p er t heir discreti o n.  
Safet y will be e val uat e d t hr o u g h ass ess me nts of a d verse e ve nts, vital si g ns, p h ysical e x a mi nati o ns, 
cli nical la b orat or y e v al u ati o ns  (i ncl u di n g pr olacti n), a n d E C G fi n di n gs. A d diti o nall y, a si n gl e, 
o pti o nal p har mac o ge n o mic  ( 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 
partici pati o n i n t he st u d y.  
Patie nts will  ha ve a fi nal f oll o w -u p visit 2 t o 3 da ys after t he fi nal d ose of st u d y dr u g  t o assess 
a d verse e v e nts, c h a n ge s t o c o nc o mita nt me dicati o ns (i ncl u di n g use of res c ue me di cati o ns),  vital 
si g ns, a n d f or P K sa m pli n g. U nsc he d ule d visits a n d/ or a dditi o nal f oll o w -u p ma y b e re q u ire d at t he 
discreti o n of t he I n vesti gat or. F or e x a m ple, patie nts wit h cli nicall y si g nifica nt a b n or mal la b orat or y 
fi n di n gs, u nres ol ve d treat me nt-e mer ge nt a d verse e ve nts  ( T E A Es), seri o us a d verse e ve nts ( S A Es) 
t hat re q uire f oll ow -u p l a b orat ories a n d re vie w, or  cli nicall y si g nifica nt a d verse e v e nts ma y 
necessitate f urt her assess me nts.  
Fi g ure 1  prese nts a st u d y sc he matic.  
Fi g ure 1 . St u d y Sc he m atic  
 
* F or eac h co h ort, s u bjects will be ra n d o mize d t o CI N -1 0 2 or place b o. Ra n d o mizati o n ma y occ ur o n Da y 1 or at a s e parate visit 
o n Da y -1.  
BI D = t wice dail y; D R C = Data Re vie w C o m mittee; G E B T = gastric e m pt yi n g breat h test . 
3. 2  
St u d y I n dic ati o n  
CI N -1 0 2 is bei n g de vel o pe d f or t he tr eat me nt a n d relief of s y m pt o ms ass ociate d wit h ac ut e a n d 
rec urre nt gastr o p aresis. 
S e q u e nti al or P ar all el 
E nr oll m e nt
Scr e e ni ng
D a ys -2 8 t o -8
B as eli n e G E B T
D a ys -7 t o -2
C o h ort 1
CI N -1 0 2  
 BI D
Pl ac e b o BI D *
C o h ort 2
CI N -1 0 2  
 BI D
Pl ac e b o BI D *
D R C R e vi e w
C o h ort 3
CI N -1 0 2  
 BI D
Pl ac e b o BI D *
F oll o w -u p
2 -3 d a ys aft er 
t h e l ast d os e
D o u bl e -bli n d tr e at m e nt 
p eri o d
BI D d osi ng fr o m t h e m or ni ng of 
D a y 1 t hr o ug h t h e m or ni ng of 
D a y 1 4 ( +/ - 2 d a ys)

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
2 5  
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 mellit 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 d ia g n osis of dia betic gastr o p aresis as defi ne d b y t he f oll o wi n g: 
o  Has u p per gastr oi ntesti nal ( GI ) s y m pt o ms felt t o be co 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, a n ore xia, bl oati n g, 
e pi gastric or a b d o mi nal p ai 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 dela ye d gastri c e m pt yi n g ( D G E) wit hi n t he pa st 3  year s 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 me n te 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 mass i n de x ( B MI) b et wee n 1 8 a n d 3 5  k g/ m 2, i ncl usi ve. 
5.  Has g l yc os yl ate d he m o gl o bi n le vel 1 1 % . 
6.  Male patie nt s wit h fe mal e part ners of c hil d-beari n g p ote ntial m ust a gree t o use 2 me 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 nt s 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 nal s per mici de, cer vi cal ca p 
wit h s per mici de, i n d we lli 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 nt s 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 he fi n al d ose of st u d y dr u g. 
8.  Fe male patie nt s wit h male part ners 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 me 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 ve 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 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 fe male pati e nt s wit h male 
part ners i n cl u de t he f oll o wi n g: lat e 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 de, 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 n e 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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
2 6  
1 0.
 
 
1 1.  Is able t o u n dersta n d a n d willi n g t o c o m pl y wit h all st u d y vis its, pr oce d ures, restricti o ns, 
disc o nti n uati o n of me 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 x cl u de d fr o m partici pati o n i n t he st u d y:  
1.  Has a h ist 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 dia, 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 discrecti o n . 
2.  Has c li 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 per mi n ute, si n us 
n o de d ysf u ncti o n, or heart bl oc k.  
3.  Has p r 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 Tc F) 
( Q Tc F > 4 5 0  mse c 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 plicat e 
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 or sa des de p oi ntes, or ot her c o m ple x 
ve ntric ular arr h yt h mias or  fa mil y hist or y of s u d de n deat h. 
5.  Has e vi d e nce ( bas e 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 , car di o vasc ular, h e patic, 
ps yc hiatric, ne ur ol o gi c, or aller gic disease (i ncl u di n g dr u g aller gies); s ur gical c o n diti o ns; 
ca ncer ( wit h t he e x ce 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 ve d or h as bee n i n re missi o n f or > 5 years pri or to 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 he 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 we d. 
6.  Has a h ist or y of pr ol acti n -rele asi n g pit uitar y t u m or (ie, pr olacti n o ma). 
7.  Has e le vat e 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 olacti n at t he ti m e of scree ni n g m a y 
be c o nsi dere 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 malities 
(e g, oli g o me 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 ur es t hat 
i n t he I n v esti gat 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 he c o urse 
of t he st u d y.  
1 0.  Has b ilir u bi n, al kali ne p h os p hatase, as partat e a mi n otra nsferase, ala ni ne a mi n otra nsferas e , or 
creati ni ne le v els great er t ha n 1. 5 ×  t he u p per li mit of n or mal at scree ni n g, or h e m o gl o bi n 
< 1 0  g/ d L at scree ni n g.  

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1 1.  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 scree ni n g, as j u d ge d b y 
t he In v esti gat or.  
1 2.  Has i na bilit y t o perf or m a breat h test.  
1 3.  Has k n o w n aller g y t o e g gs or s pir uli na.  
1 4.  U se of  i n vesti gati o nal, pr escri 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 artici pati n g i n a n e x peri me n tal t hera p y st u d y; recei ve d e x peri me 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 mizati o n  or 5 half -li ves (w hic he ver is 
l o n ger); or recei ve d e x peri me 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 ves, (w hic he v er  is l o n ger). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5.  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 ostic 
a n d Statistical Ma n ual of Me ntal Dis or ders, 4t h E diti o n.  
1 6.  T y pic al c o ns u m pti o n of 1 4 alc o h olic dri n ks wee kl y.  
1 7.  Hist or y or e vi de nce of illicit dr u g use.  
1 8.  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 h e patitis B s urface a nti ge n  ( H Bs A g) at t he Scree ni n g Visit.  
1 9.  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 0.  C urre ntl y u n der g oi n g tr eat me nt wit h 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).  
2 1.  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 2.  I n a bilit y t o s wall o w me dicati o n. 
2 3.  C urre ntl y recei vi n g p are nteral fee di n g or pres e n ce of a n as o g astric or ot her e nteral t u be 
(e g, perc u ta ne o us e n d osc o pic gastr o n o m y[ P E G] t u be) f or fee di n g or dec o m pressi o n. 

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2 4.  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 her GI  mec ha nical 
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 seri es i n t he 
past 3 years.  
2 5.  K n o w n hist or y or c urre nt dia g n osis of i ntesti nal mala bs or pti o n or pa ncreatic e x ocri ne disease.  
2 6.  Hist or y of gastri c s ur ger y s uc h as f u n d o plicati o n, gastr ect o m y, va g ot o m y, p yl or o plast y, or 
bariatric pr oce d ure.  
N ote: Patie nts w h o ha ve a gastric pace ma ker i n place ma y b e c o nsi dere 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 ne G E B T a n d t hr o u g h o ut t he 
re mai n der of t he st u d y. 
N ote : 
A hist or y of dia g n ostic e n d os c o p y is n ot e x cl 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 7.  Hist or y or pres e nce of a n y me dical c o n diti o n or ps yc hiatric 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.  
2 8.  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 perse nsiti vit y  or i nt olera nce  t o 
d o m peri d o ne or a n y of t he e x ci pie nts i n t he CI N -1 0 2 f or m ulati o n.  
2 9.  J u d ge d b y t he 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 patie nt at i ncrease d ris k d uri n g p artici 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 mes. 
4. 3  
R a n d o miz ati o n Crit eri 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 he f oll o wi n g criteri a at t he ti me of ra n d o mizati o n : 
 C o nti n ues t o satisf y all incl usi o n/ ex cl usi o n criteria . 
 Has bee n o ff 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 x c e pt f or pr ot oc ol -s pecifie d a ntie metic rescue 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 he f oll o wi n g:  
o  C urre nt u p per GI s y m pt o ms (e g , p ost pra n di al na usea/ v o miti n g, p ost pra n dial f ull ness, earl y 
satiet y, a n ore xia, bl oati n g, e pi gastric, or a b d o mi n al pai n) . 
o  D oc u me nte d D G E wit hi n t he 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 na 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  

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 Has c o nti n ue d re q uire d res ults of t he i nitial safet y la b orat or y test perf or me d at Scree ni n g.  
4. 4  
Wit h dr a w al Criteri a  
Partici pati o n of a patie nt  i n t his cli nical st u d y ma y be disc o nti n ue d f or a n y of t he f oll o wi n g 
reas o ns: 
 P atie nt wit h dra ws c o nse nt or re q uests d isc o nti n uati on fr o m t he st u d y f or a n y reas o n . 
 O cc urre nce of a n y me di cal c o n diti o n or circ u msta nce t hat e x p oses t he patie nt  t o s u bsta ntial 
ris k a n d/ or d oes n ot all o w t he patie nt  t o a d here t o the re q uire m e nts of t he pr ot oc ol . 
 A n y S A E , cli nic all y si g nifica nt a d v erse e ve nt, s e vere la b orat or y a b n or m alit y, i nterc urre nt 
ill ness, or ot her 
me dical c o n diti o n w hic h i n dicates t o t he I n v esti gat or t hat c o nti n ue d 
partici pati o n is n ot i n t he best i nterest of t he patie nt . 
 Pre g n a nc y . 
 Re q uire me nt of pr o hi bite d c o nc o mita nt me d icati o n. 
 Patie nt  fail ure t o c o m pl y wit h pr ot oc ol re q uire me nts or st u d y -relate d pr oce d ures. 
 Ter mi nati o n of t he st u d y b y t he S p o n s or or t h e re g ulat or y a ut h orit y. 
If a p atie nt  wit h dra ws pre mat urel y fr o m t he st u d y d u e t o t he a b o v e criteria or a n y ot h er reas o n, 
st u d y staff s h o ul d ma ke e ver y eff ort t o c o m plete t he f ull pa nel of assess me nts sc he d ule d f or t he 
Earl y Ter mi nati o n Visit . T he reas o n f or p atie nt  wit h dra wal m ust b e d oc u m e n te d i n t he electr o nic 
case re p ort for m (e C R F).  
St u d y e nr oll me nt will c o nti n ue u ntil 6 0 patie nts ( 1 5  patie nts  per treat me nt ) ha ve c o m plet e d t he 
treat me nt peri o d. Wit h dra w n patie nt s will n ot be re place d.  

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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 me 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 xcl usi o n a n d 
ra n d o mizati o n criteria) will be 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 patie 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 u c h t hat 1 5 s u bjects recei ve CI N -1 0 2 a n d 5 s u bjects recei ve place b o. After C o h ort  1 
c o m pletes t he st u d y, a D R C  will c o n ve ne t o re vie w t he data fr o m C o h ort 1.  C urre n tl 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 p ecti 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 hese pla n ne d d ose 
le vels ma y b e m o difie 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 her 
o n g oi n g st u dies. T h e hi g hest d ose will n ot e x cee d  
 BI D wit h o ut a pr ot oc ol a me n d me nt. T h e 
s u bse q ue nt c o h orts ( C o h orts 2 a n d 3) ma y be e nr olle d se q ue ntiall y or si m ulta ne o usl y. 
T he d urati o n of t he d o u ble -bli n d treat me 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 dat e: 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). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 ncl usi o n , n o ne of t he 
e x cl usi o n criteria , a n d all of t he a d diti o nal criteria at t he ti me of ra n d o mizati o n, i ncl u di n g safet y 
la b orat or y tests (s ee Secti o n 6. 5 ), will be ra n d o mi ze d i nt o t he st u d y.  Ra n d o mizati o n s h o ul d occ ur 
o n Da y  1  (alt h o u g h it ma y als o occ ur o n Da y -1, as necess ar y) . Ra n d o mizati o n assi g n me nts will 
be 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. T he S p o ns or  a n d all cli nical pers o n nel will be 

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bli n de d t o t he treat me nt gr o u p f or eac h patie nt . P atie nt s will als o be bli n de d t o t he treat me nt t he y 
recei v e.  
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 me nt eit her via 
recei pt of t he 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 nt s 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 place b o) , or b y t h e nat ur e 
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 des cri pti ve 
statistics, perf 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 data, 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 necessar y b y t he I n vesti gat or f or 
e mer ge n c y sit uati o ns f or reas o ns of patie n t 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 he 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 h e I n vesti gat or will be i nf or me d of  tr eat me 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 p arati 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 wi ll fast f or a mi ni m u m of 8 h o urs bef ore a n d 4 h o urs after 
t he m or ni n g d ose o n t he da ys w he n t he G E B T a n d serial P K dra ws will be perf or me d (Da ys 1  a n d 
1 4 [± 2  da ys]).  
 D uri n g 
c o nfi ne m e 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 he site b y site staff. Patie nts 
will be pr o vi de d st u d y dr u g f or self -a d mi nistrati o n f or st u d y d a ys n ot at t he site.  
5. 5. 4  
Treat me nt C o m plia nce  
S t u d y dr u g will be a d mi nistere d at t he site b y site staff  d uri n g patie 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 

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c o m plia nce. D osi n g c o m plia 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 m e of st u d y dr u g a d mi nistrati o n will be rec or de d.  
O n da ys t hat t he patie nt is n ot at t he 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 date a n d ti me of st u d y dr u g a d mi nistrati o n. C o m plia nce t o st u d y dr u g  will als o be assesse d b y 
cli nical site pers o n nel vi a ta blet c o u nts of ret ur ne d st u d y dr u g a n d b y q u esti o ni n g t he patie nt, if 
necessar y , u p o n ret ur n t o t he site o n Da ys 3  [± 1 da y],  7  [± 1  da ys],  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 defi n e d as ha vi n g ta ke n 7 5 %  of st u d y dr u g) 
will be c o u nsele d at e ac 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 dr a ws fr o m t he st u d y or d o es n ot c o m pl y wit h t he 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 h e st u d y b ut will still be c o nsi dere 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 oc 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 nati 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 he st u d y, a n y u n use d st u d y dr u g will be 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 destr 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 Acc 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 ures  
5. 6. 1  
E x cl u de d Me dicati o ns 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 me 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 mizati o n or 
5  half -li ves (w hic h e ver is l o n ger ); or e x peri me ntal t hera p y wit h a lar 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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 P yl oric i njecti o n of b ot u li n u m t o xi n wit hi n 6 m o nt hs of scree ni n g a n d d uri n g t h e c o urse of t he 
st u d y. 
 W ei 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). 
 P are nteral fee di n g or pres e nce of a nas o g astric 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 pr essi o n.  
5. 6. 2  
Restricte d Me dicati o ns a n d/ or Pr oce d ures  
Resc ue Me dic ati o ns  
 
 Patie nts w h o re q uire 
f urt her tr eat me nt wit h pr o hi bite d me dicati o ns ma y b e disc o nti n ue d fr o m st u dy treat me nt (at 
discreti o n of t he I n v esti 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 me dicati o ns t hat are n ot e x plicitl 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 me 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.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
3 4  
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 nse nt 
Writte n i nf or me d c o nse nt f or t he st u d y will be o btai ne d fr o m all 
patie nt s 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 ar 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 ma y 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. I n or der t o ha 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 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 partici 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 details 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 p r oce 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 mes f or 
eli gi bilit y p ur p os es.  
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 miza ti o n ( bet wee n 
Da ys  -2 8  a n d -8 ). T he f oll o wi n g pr oce d ures will be pe rf or me d at t he Scree 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 xcl 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 x a mi nati o n  (ge neral a p peara nce, 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 h t a n d wei g ht a n d calc ulate B MI. 
 Perf or m breat h alc o h ol test.  
 C ollect uri ne sa m ple s 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 ur e) w hile  
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 matel 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 f or safet y a n al ysis will be pri nte d at sc h e 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 In vesti gat or or S u bi n vesti gat or.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
3 5  
 C ollect bl o o d s a 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 olacti n.  
o  F S H ( o nl y f or fe males w h o ha ve bee n p ost me n o pa usal f or at least 1 year a n d are n ot 
s ur gic all 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 me 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 ne G astric E m pt yi n g Bre at h Tes t Visit ( D a ys -7  t o -2 ) 
B aseli ne G E B T will be p erf or me d b et wee n Da y s -7  a n d -1  after a mi ni m u m 1 4 -da y  was 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 Bas eli ne G E B T  Visit ( Da ys -7  t o -2 ): 
 Assess f asti 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 uc ose of 
2 7 5 m g/ d L . 
 O btai n b reat h sa m ples f or G E B T t wi ce pri or t o c o ns u mp ti o n of a st a n dar dize d, 1 3C -e nric he d 
meal per t he 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 6 -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 ur e) w hile 
patie nt is sitti n g after a mi ni m u m 5 -mi n ute rest.  
 C ollect 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 ) 
E li gi ble patie nts will be ra n d o mize d t o recei ve CI N -1 0 2  or place b o.  Ra n d o mizati o n will  occ u r 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 p arate 
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 ( Da y -1) t o all o w a d e 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 tests (ie, c he mistr y, h e mat olo g y, 
c oa g ulati o n, a n d uri nal ysis) fr o m Da y -1 or Da 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 . B l o o d a n d uri ne sa m ples f or cli nical safet y l a b orat or y tests will als o 
be se nt t o t he ce ntral la b orat or y f or a nal ysis. Eli gi bi lit y ma y be b ase d o n Scree ni n g pr olacti 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 mizati o n ( Da y -1  or Da y 1 ): 
 Assess eli gi bilit y b ase d o n i ncl usi o n/e xcl usi o n a n d ra n d o mizati o n criteria.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
3 6  
 Rec or d me dic al/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 nce, 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 ollect uri ne sa m ple s for t he f oll o wi n g:  
o  Uri nal ysis.  
o  P oi nt -of -care ( P O C) u ri 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 ur e) w hile 
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 matel 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 f or safet y a n al ysis 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 so o n as p ossi ble b y t he I n v esti gat or. 
 C ollect 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 olacti n.  
N ote: Pr olacti n res ults are n ot re q uire d pre -ra n d o mizati o n. 
 C ollect 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]).  
 
 
 
 
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  Da 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 ur e) w hile 
patie nt  is sitti n g after a mi ni m u m 5-mi n ute rest.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
3 7  
 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 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 f or safet y a n al ysis 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 v esti gat or. 
 A d mi nister st u d y dr u g (all patie nts  will ta k e 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 
 
 
 
 
 D is pe nse t he necessar y a m o u nt of st u d y dr u g f or self-a d mi nistrati o n  f or Da y 2 (a n d Da y 3 
[± 1  da y ] as n ee de d) . 
 C ollect bl o o d sa m ples f or t he f oll o wi n g:  
o  P r olacti n. Sa m ple c ollect e d pre d ose.   
o  P K a nal ysis 
 
 
 
 
 
 
 
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 k e 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 D a y) 
T he f oll o wi n g pr oce d ures will be perf or me d as a n o ut patie 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 ollect 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 ur e) w hile 
patie nt  is sitti n g after a mi ni m u m 5-mi n ute rest.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
3 8  
 Perf or m 1 2 -lea d E C G (i n tri plicate a p pr o xi matel 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 f or safet y a n al ysis 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 v esti gat or. 
 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 
 
 
  
 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.  
 Dis pe nse  t he necessar y a m o u nt of st u d y dr u g f or self-a d mi nistrati o n Da ys 4, 5, a n d 6 (a n d 
Da y  7 [ ± 1 da y] as nee de d) . 
 C ollect 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 olacti n. Sa m ple c ollecte d pre d ose.  
o  P K a nal ysis 
 
 
 
 
 
 
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 k e 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  D a y) 
T he f oll o wi n g pr oce d ures will be perf or me d as a n o ut patie 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 ollect 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 ur e) w hile 
patie nt  is sitti n g after a mi ni m u m 5-mi n ute rest.  
 A d mi ni ster st u d y dr u g (all patie nts will ta k e 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 
 
 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
4 0  
 C ollect 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 olacti n. Sa m ple c ollect e d pre d ose.  
o  P K a nal ysis 
 
 
 
 
 
 
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 D a 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 k e 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 D a ys ) 
T he f oll o wi n g pr oce d ures will be perf or me d o n Da 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 ollect uri ne sa m ple s 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 x a mi nati o n ( ge neral a p peara nce, 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 r ate, bl o o d press ure, res pirati o n rate, a n d te m perat ur e) w hile 
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 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 f or safet y a n al ysis 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 nv esti gat or.  
 Assess fasti n g  bl o o d gl u c ose will be assesse d bef 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 uc 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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
4 1  
 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 
 
 
 
 
 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 ollect 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 olacti n . Sa m ple c ollecte 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 me n o pa usal ra n ge at t he Scree ni n g Visit]). 
o  P K a nal ysis 
 
 
 
 
 
 O btai n b reat h sa m ples f or G E B T (t wice pri or t o c o ns u mp ti o n of a sta n dar dize d, 1 3C -e nric he d 
meal 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 ). 
 
 
 
6. 6. 1 0  
Da y 1 5  
T he f oll o wi n g pr oce d ure s will be perf or me d as a n o ut patie 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 ur e) w hile 
patie nt  is sitti n g after a mi ni m u m 5-mi n ute rest.  
 C ollect bl o o d sa m ples f or P K a nal ysis.  
6. 7  
F oll o w -u p Visit ( D a ys 1 6 t o 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 da ys ( Da ys 1 6 t o 1 7) after t he last d ose 
of st u d y dr u g. T h e f oll o wi n g pr oce d ures will be perf or me d at t he f oll o w -u p visit ( Da ys 1 6 t o 1 7 ): 
 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 ur e) w hile 
patie nt  is sitti n g after a mi ni m u m 5-mi n ute rest.  
 
 
 C ollect bl o o d sa m ples f or P K a nal ysis.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
4 2  
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 nt s 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 he 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 dize d, 1 3C -e nric he d 
meal 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 ). 
 
 
 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 ollect uri ne sa m ple f or uri nal ysis.  
 Perf or m c o m plete p h ysi cal e x a mi nati o n ( ge neral a p peara nce, 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 ur e) w hile 
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 matel 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 on f or at least 1 0 mi n utes ).  
N ote : 1 2-lea d E C Gs f or safet y a n al ysis 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 v esti gat or. 
 C ollect 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 olacti 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 me n o pa usal ra n ge]). 
o  P K a nal ysis.  

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Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
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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 b le is t he c ha n ge fr o m baseli ne ( gat here d o n Da ys -7 t o -2) i n gastri c 
e m pt yi n g as me as 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 ve sta 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 ne t he rate of gastric e m pt yi n g after c o ns u m pti o n of a sta n dar dize d, 1 3C -e nric he d 
meal. Patie nts will c o ns u me a sta n dar dize d, 
1 3C -e nric h e d meal after a 6 -h o ur fast at baseli ne 
( Da ys -7 t o -2) a n d aft er a 6 -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 aft er meal c o ns u m pti o n after 
a 6-h o ur fast o n D a ys -7 t o -2  a n d D a y 1 4 ( ± 2 da ys) a n d 3 0 mi n ute s 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 he f oll o wi n g:  
 T he c ha n ge fr o m bas eli ne i n gastric e m pt yi n g ter mi nal p hase eli mi nati o n half-life ( T½ ) as 
meas ure d b y G E B T at D a 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 oc ol CI N -1 0 2 -1 2 1  
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7. 4  
P h ar m a c o ki netics  
Bl o o d  sa m ples f or P K a n al yses will be c ollect e d pri or t o t he m or ni n g d ose 
 
 
a n d 
 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 yses will als o be c ollecte 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 ollecti 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 Da 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 ntr ati o ns m eas ure d f oll o wi n g t he fi nal d ose of CI N -1 0 2, 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  
 A U C fr o m ti me 0 t o t he ti me of t he last q ua ntifia ble plas ma 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  

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Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
4 5  
 A p pare nt plas ma cleara n ce  
 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 ollecte 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 ar 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 ma y  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 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 be gi ve n t he o pti o n t o partici pate i n t he P G x assess me 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. See 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 uclei c 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 n etic data bas e. T h e res ults o btai ne d fr o m 
a nal ysis o f t h e P G x sa m ples will be 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 be discl ose d t o t he I n vesti gat or b ut are n ot i nte n de d t o be pr o vi de d t o t he patie 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 he patie nt’s pers o nal i de ntificati o n 
i nf or mati o n. 
7. 5. 1  
C ollecti 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 parti ci pate i n t he o pti o nal P G x assess me 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 ollecti 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 de ntifier. G o o d La b orat or y Practi ce re q uir es a c hai n of 
c ust o d y t h at is tracea ble t o t he sa m ple d o n or. T o  e ns ure patie nt c o nfi de ntialit 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 h a uste d or u ntil t he 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 
w it 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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
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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 me di cal occ urre n ce i n a cli nical 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 me 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 mal l a b orat or y fi n di n g), s y m pt o m, or disease te m p orall y ass ociate d wit h t he 
use of a n i n vesti gati o nal me dici nal pr o d uct w het h er or n ot relate d t o t he i n ves ti gati o nal me dici n al 
pr o d uct. All a d verse e ve nts, i ncl 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 he a p pr o priate e C R F. 
A d verse 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 partici pati o n is c o m plete. Patie nt s 
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 nce t o t he I n vesti gat 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 me of first d ose of st u d y dr u g, I n vesti gat ors s h o ul d ma 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 he e ve nt o n t he a p pr o priate a d verse e ve nt e C R F.  
W here ver p ossi ble, a s p ecific dise ase or s y n dr o me rat her t ha 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 be 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 we 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 dere d a c o m p o ne nt of a s pecific dise ase 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 verse e ve nt o n t he e C R F. 
A d diti o nall y, t he c o n diti o n t hat le d t o a me dical or s ur gical pr oce 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 v e nt, n ot t he pr oce d ure itself.  
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 de d 
as me dical hist or y a n d n ot be re p orte d as a n a d verse e v e 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 prese 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 me d uri n g 
t he st u d y. I n t his cas e, it s h o ul d be re porte 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 x a mi nati o n (e g, E C G) fi n di n gs t hat 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 ost 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 o rte d as a d verse e ve nts, as d escri be d b el o w. T he I n vesti gat or 
will e x ercise his or her me dical a n d sci e ntific j u d g me 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 p eat 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 m al test res ults t hat are 
deter mi ne 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 malities) 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 ve 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 he 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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
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8. 1. 1  
A d verse ( Dr u g) Reacti 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 dered a n a d vers e dr u g reacti o n . “ Resp 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 wee n a me dici 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 Reacti o n  
A n U ne x pecte d A d verse Dr u g Rea cti 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 he 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 he I n vesti gat or  
T he I n v esti gat or will assess t he se verit y (i nte nsit y) of eac h a d verse e ve nt  as mil d, m o derate, or 
se vere, a n d will als o cat e g orize eac h a d verse e ve nt as t o its p ot e ntial rel ati o ns hi p t o st u d y  dr u g 
usi n g t he cate g ories of y es or n o . 
Assess me nt of se verit y: 
Mil d –  A n e ve nt t hat is easil y t olerate d a n d ge nerall y n ot i nterferi n g wit h  n or mal dail y acti vities.  
M o derate –  A n e ve nt t hat is s ufficie ntl y disc o mf orti n g t o i nterfere wit h n or mal dail y acti vities.  
Se vere –  A n e ve nt t hat is i nca pacitati n g wit h i na bilit y t o w or k or perf or m n or mal dail y acti vities.  
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 rel ate d, u nli kel y t o be relate d ) –  T he ti me 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 ors e ni n g of t he a d verse e ve nt r ul es o ut a ca usal relati o ns hi p 
a n d a n ot her ca use (c o nc o mita nt dr u gs, t hera pies, c o m plicati o ns, etc.) is s us pecte d.  
Yes ( p ossi bl y, pr o ba bl y, or defi nitel y relate d ) –  T he ti me 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 verse e ve nt is c o nsiste nt wit h a ca usal 
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 wee 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 here are facts (e vi de 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 dere 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 uat e 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 mita 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 he 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 diseas e t he patie nt  ma y h a ve.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
4 8  
 C o nc o mita nt dr u g - 
o  T he ot her dr u gs t he patie nt  is ta ki n g or t he treat me 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 he m mi g ht be rec o g nize d t o  ca use t he 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 kel 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 str e ss 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 mac ol o g y a n d P K  of t he st u d y dr u g - 
o  T he k n o w n p h ar mac 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 verse E ve nt s 
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 he vie w of eit her t he I n vesti gat 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 vers e 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 hr eate 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 he patie nt  at i m me diate ris k of deat h. It d oes 
n ot i ncl 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 ve ca use d d eat h.  
 Re q uires h os pitaliz ati o n or pr ol o n gati o n of e xisti n g h os pitalizati 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 pitaliz ati o n. A n e mer ge n c 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 
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 ve 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 ne. H o we 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 pitaliz ati o n t hat occ ur d uri n g electi ve s ur ger y s h o ul d be rec or de d as a d verse e ve nt s a n d 
assesse d f or seri o us ness.  A d missi o n t o t he h os pital f or s ocial or sit uati o nal reas o ns ( i e, 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 pital visits, res pite care) will n ot be c o nsi dere d 
i n patie nt h os pitaliz ati o ns.  
 A persiste nt or si g nifica nt disa bilit y/i nca p acit 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 ncti o ns . 
 A c o n ge nital 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 me dical j u d g me nt, t he y ma y je o par dize t he patie nt  a n d 
ma y re q uire m e dical or s ur gic a l i nter ve nti o n t o pre ve nt 1 of t he o utc o mes liste d a b o ve. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
4 9  
E x a m ples of s uc h me 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 me nt 
i n a n e mer ge nc y r o o m or at h o me, 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 verse E ve nt Re p orti n g − Pr oce d ures f or I n vesti g at ors  
I nitial 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 he k n o wle d ge of 
t he occ urre nce. After t he 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 he S p o ns or/ desi g n ee. Of n ot e, 
re p orti n g of S A Es after t he f oll o w-u p p h o ne call 7 2 h o urs after d isc 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 he site t o re p ort a n y s u c h e v e nts.  
T o re p ort t he S A E, c o m plete t he 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 he st u d y. W he n t he 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 he E D C s yste 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 ne 
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 bel o w) wit hi n 2 4 h o urs of a ware ness. W he n t he E D C s yste m bec o mes a vaila ble, t he 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 nta ct I nf or m ati o n: 
 
 
 
 
 
F oll o w -U p Re p orts  
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 he 
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 ntati o n 
(e g, patie nt  disc har ge s u m mar y or a ut o p s y re p orts) t o 
 via fa x or e-mail. 
If it is n ot p ossi ble t o access t he 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 patie 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 ne 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 nati o n pr oce d ures s h o ul d b e i m ple me nte d at t hat ti me.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
5 0  
A pre g n a nc y is n ot c o n si 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 ge 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 
In 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 he safet y f oll o w -u p peri o d d efi ne d i n t he pr ot o c 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 he ne ver p ossi ble. O nce 
t he o utc o me of t he 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 pleted  a n d fa x e 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 gat or s h o ul d f oll o w t he pr oce 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 verse 
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 va 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 her s us pecte d u ne x pecte d seri o us a d verse 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 uir e d.  
8. 6  
Cli nic 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 ncl 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 pe 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 be e val uate d at t he ti mes i n dicate d i n t he  Sc he d ule o f 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.  
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 paris o n t o t he val ue at t he ti me of ra n d o mizati o n or u nres ol ve d T E A E s, a d diti o nal 
f oll o w-u p visits will be s c he d ule d. Patie nt s will b e f oll o we d a p pr o xi matel y o n ce a wee k ( or m or e 
fre q ue ntl y as dee me d a p pr o priate) u ntil t he I n vesti gat or d eter mi nes t hat re p eat la b orat or y fi n di n gs 
are cli nicall y u nre mar 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 nic all y acce pta ble l e vels.  
If a patie nt  e x perie nces a n S A E f or w hic h f oll o w -u p la 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 necessar 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 he 
f oll ow -u p call, t he I n vesti gat or will pr o vi de a d diti o nal f oll o w -u p u ntil t he a d verse e v e nt ret ur ns t o 
cli nicall y acce pta ble le v els.  
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. 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
5 1  
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 dicat e 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  usi n g t he f oll o wi n g 
sta n dar dize d pr oce d ures: 
 Pri or t o meas uri n g vital 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/ her bac k s u p p orte d, feet flat o n t he fl o or, a n d his / her meas 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 ma n o meter c uff is at heart le vel. 
 A n a p pr o priat el y siz e 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 siz e 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 ur e s h o ul d be rec or de 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 -le a d E C Gs will b e perf or me d at t he ti mes i n dicate d i n t h e Sc he d ul e of Pr oce d ures t a ble 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 el ectri cal i nterfere nce. D uri n g t hes e assess me nts, patie nt s 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 perat e d or electri cal de vice, 
a n d all of t hese d e vices m ust be t ur ne d off d uri n g t he 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 matel 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 me nts. T wel ve -lea d E C Gs f or safet y an al ysis will be pri nte d at t he 
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 a n I n v esti gat or  ( or 
S u bi n vesti gat or f or Scree ni n g Visit o nl y) . All E C Gs c ollecte d at t he ti m e of ra n d o mizati o n a n d 
t hr o u g h o ut t he treat me nt peri o d m ust be e val uate d f or t he prese n ce of a b n or malities b y a q u alifie d 
p h ysicia n.  
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 m eters will be rec or de d:  
 Q R S i nter val  
 Heart rate  
 R R i nter val  
 Q T i nter val  
 Q Tc ( Q Tc F  a n d heart rate -c orrecte d Q T i nter val  usi n g Bazett’s f or m ula  [ Q Tc B] f or 
c o m paris o n t o hist orical Q Tc B  d ata of  d o m peri d o ne ) 
8. 9  
P h ysic al E x a mi n ati o ns  
C o m plete p h ysic al 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 ta ble i n A p pe n di x  A . A c o m plete p h ysical e x a mi nati 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 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.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
5 2  
Brief li mite d p h ysic al e x a mi nati o ns will be perf or me d at t he ti mes i n dicat e d i n t he Sc he d ul e 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 x a 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 ur e 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. Hei g ht will be meas ure d wit h t he patie nt ’s s h oes 
off. Wei g ht will be meas ure d wit h t he patie nt ’s s h oes off a n d after t h e patie n t’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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
5 4  
9. 2. 1. 5  
P har mac o ki netic a n al 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 d i vi d ual a n d 
s u m marize d b y treat me nt f or acti ve treat me 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 be 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. 6  
P har mac o ki netic -P har mac o d y n a mic a n al ysis  
A n atte m pt  ma y  b e ma d e t o c haract erize e x p os ure -res p o ns e relati o ns hi ps f or meas ures of safet y 
a n d/ or effficac y. 
9. 2. 2  
A nal ysis of Safet y  
Safet y data, i n cl u di n g p h ysical e x a mi nati 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 verse e ve nts, will be s u m marize d b y treat me nt gr o u p a n d 
ti me 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 val ues 
a n d c ha n ge fr o m bas eli ne pr olacti n b y treat me 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 data, as well as f or t he differe nce fr o m b aseli ne, w he n 
a p pr o priate. A bs ol ute a n d c ha n ge fr o m bas eli ne val ues i n Q T ( usi n g Q Tc F a n d Q Tc B) will be 
pl ot te d a gai nst ti me p oi nts b y treat me nt, if a p plica ble. 
S hift ta bles descri bi n g o ut -of -n or mal r a 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 nterim  A nal ysis  
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 data t hr o u g h o ut t h e 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 he pr o p ose d d ose le vels is warra nte d. T he 
D R C will als o deter mi ne h o w t o a d va n ce t h e c o h orts (s eriall y or si m ulta ne o usl y). 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 he D R C will be pr o vi de d i n t he 
D R C  C harter.  
9. 2. 4  
Sa m ple Siz e Deter mi nati o n  
A t otal of 6 0 patie nts ( 1 5 patie nts  per gr o u p) will be ra n d o mize d t o CI N-1 0 2 
 BID, 
CI N -1 0 2  
 BI D, CI N-1 0 2 
 BI D, or place b o . T he sa m ple siz e is c o nsi dere d a de q u ate t o 
pr o vi de t he necessar y dat a t o e val uate t he o bjecti ves of t he st u d y. N o f or mal statistical assess me nt 
f or sa m ple siz e deter mi n ati o n has bee n perf or m e d.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
5 5  
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 de 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 researc h ass oci ate ( 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 he 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 tr ac ke d i n a n 
a u dit trail i n t he E D C s yste 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 has bee n acc o u nte d f or.  
1 0. 1. 2  
C o m p uter S yste 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 he E D C s yste m as t he st u d y is i n pr o gress. All site pers o n nel m ust 
l o g i nt o t he s yste m usi n g t heir sec ure user na me a n d pass w or d i n or d er 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 Part 1 1) a n d ot he r 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 dic al i nf or mati o n, t he f oll o wi n g t hes a uri will be use d:  
 Me dical Dicti o nar y f or R e g ul at or y Acti vities  (latest) f or me dical hist or y a n d a d verse e ve nts  
 W orl d Healt h Or ga niz ati o n Dr u g Dicti o nar y f or pr i or a n d c o n c o mita nt me dicati 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 well as s u p ple me ntal vali dati o n 
perf or me d via re vie w of t he d o w nl oa de d data, will be a p plie d t o t he data i n or der t o e ns ure 
acc urate, c o nsiste nt, a n d relia ble data. Data 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 ueri es.  
T he e C R Fs m ust be re vi e we d a n d el ectr o nicall y si g ne d b y t h e I n vesti gat or. 
1 0. 2  
Rec or d Kee pi n g  
Rec or ds of p atie nt s, s o ur ce 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 he st u d y m ust be ke pt i n 
t he a p pr o priate st u d y files at t he site. S o urce data is defi ne d as all i nf or mati o n i n ori gi nal rec or ds 
a n d certifie d c o pies of ori gi nal rec 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 n ical st u d y. S o urce d ata are 
c o ntai ne d i n s o urce d oc u me nts ( ori gi nal rec or ds or certifi e 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 me 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.  

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Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
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1 1  
IN 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 uct 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 nt s. C o m plia nce 
wit h t his sta n dar d pr o vi d es p u blic ass ur a nce t hat t he ri g hts, safet y, a n d well -bei n g  of st u d y p a tie nts 
are pr otect e d, c o nsiste nt wit h t he pri nci ples t hat h a ve t heir ori gi n i n t he Declarati o n of Helsi 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 vie 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 pri ate 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 nt s. 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 val has bee n o btai ne d. T he pr ot oc ol, I n vesti gat or’s Br oc h ure, I C F, a d vertise me nts 
(if a p plica ble), writte n i nf or mati o n gi ve n t o t he p atie nt s, 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 he In 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 nisati o n (I C H) G ui deli nes re q uire t hat 
a p pr o val be o btai ne d fr o m a n I R B pri or t o partici pati o n of patie nt s i n researc h st u dies. Pri or t o 
st u d y o nset, t he pr ot oc ol, a n y pr ot oc 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 me 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 patie 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 ve d 
b y t he S p o ns o r. 
1 1. 3  
I nf or me d C o nse nt 
T he I C F a n d a n y c h a n ges t o t he 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 gree 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 nce wit h all I C H G C P, 
l ocal re g ulat or y re q uir e me nts, a n d le gal r e q uire me nts.  
T he I n vesti gat or m ust e ns ure t hat eac h st u d y p atie nt  is f ull y i nf or me d a b o ut t he 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 hat t he 
patie nt  has bee n i nf or m e d of his/ her ri g hts t o pri vac y. T he I n vesti gat or will o btai n writte n i nf or me d 
c o nse nt fr o m eac h p a tie 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 hat c o nse nt w as o btai n e d pri or t o e nr oll me nt i n t he st u d y. T he ori gi nal 
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 pecti o n b y a 
re pres e ntati ve of t h e S p o ns or, t heir re prese nt ati 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 he 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 da nce wit h 
t he pr ot oc ol, Declarati o n of Helsi 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 d ata are e ntere d i nt o t he e C R Fs.  
T o ac hie ve t his o bjecti ve, t he C R A’s  d uties are t o ai d t he I n vesti ga t 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, le gi ble, well-or ga nize d a n d easil y retrie va ble dat a. 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 n el t he f oll o wi n g d oc u me nts: pr ot oc ol, I n v esti gat or’s Br oc h ure, e C R Fs 

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a n d pr oce d ures f or t heir 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 oc 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 verifie 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 he site, t he C R A will re vie w t he 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 hat i d e ntif y data i nc o nsiste nci es 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 clarifi cati o n or c orrecti o n will be se nt t o t he 
In 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 he 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 w ill 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 he i n vesti gati o nal site b y si g nat ur e 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 heir 
desi g nee, a p plica ble f orei g n healt h a ut h orities, a n d t he I R B as a p pr o priate. Patie nt s 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 heir pers o nal p h ysicia n or ot her 
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 o rities or t he S p o ns or, t he In v esti gat or 
will kee p rec or ds, i n cl u di n g t he i de ntit y of all p artici pati n g p atie nt s (s uffi cie nt i nf or mati o n t o li n k 
rec or ds; e g, eC 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 eC 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 he I n vesti gat 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 he Cli nical St u d y A gree me nt, w hic 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 bee n met. 
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 oti fie d. T he st u d y rec or ds m ust be tra nsferre d t o a n acce pta ble desi g nee, s uc h 
as a n ot her I n v esti gat 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 
jo 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 mitte d f or p u blicati o n. T he S p o ns or reser ves t he 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 blicati o n are ac hi e ve d. 

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Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
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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 nfor 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 rel e 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 he st u d y.  

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Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
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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 vie w a n d a p pr o val 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 bee 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 ntati o n of t he 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 oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
6 0  
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 me nt f or gastr o paresis: 
de m o gra p hic a n d p h ar mac 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 me nt of Healt h a n d H u ma n Ser vices, F o o d a n d Dr u g A d mi nistr ati 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 val uati o n of dr u gs 
f or treat me nt. G ui d a nce f or i n d ustr y [ draft g ui da nce]. J ul y 2 0 1 5. 
4 . 
Ca milleri M, B har uc h a A E, Farr u gia G. E pi de mi ol o g y,  mec ha nis ms, a n d m a na ge me nt of 
dia betic 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 varez 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 hera 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]. Mac q uari e Par k, N S W, A ustralia. 
J a nsse n-Cila g Pt y Lt d. 0 4  Fe br uar 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 milleri M, Par k ma n H P, S hafi M A, et al. Cli nical g ui deli ne: ma na ge me nt of  
gastr o p aresis. A m J G astr oe nter 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 her R M. D o m peri d o ne safet y: a mi ni -re vie w of the 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 nes A ge nc y, P har mac o vi gila nce Ris k Assess me nt C o m mittee ( 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 me 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, pla ce 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 me nt of Healt h a n d H u ma n Ser vices, F o o d a n d Dr u g A d mi nistr ati 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 val 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 ntiarr 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 nsse 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 val 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 mittee ( P C A C) Meeti n g tra nscri pt. 2 8 Oct o ber 2 0 1 5.  
 
 

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Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
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1 8 . 
B o yce MJ, Baisle y KJ, Warri n gt o n SJ. P har mac o ki ne tic 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 ues t 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/ de vel o p me nt a p pr o val pr ocess/ h o w dr u gs are d e v el o pe da n da p pr o
ve d/a p pr o vala p plic ati 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 uc 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) 

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A P P E N DI X  A:  S C H E D U L E O F P R O C E D U R E S  
T a ble 1 . Sc he d ule of Pr oce d ures  
St u d y D a y  
Scree n i n g  
B aseli ne  
G E B T  [1 6 ] 
R a n d o m iz ati o n
[2 1 ]  
Tre at me nt Peri o d  
F oll o w -u p / 
E T  
-2 8  t o -8  
-7  t o -2  
-1  or 1  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  1 1  1 2  1 3  
1 4  
1 5  
1 6 t o  1 7  
Visit  Wi n d o w ( D a ys)  
 
 
 
 
 
± 1  
 
 
 
± 1  
 
 
± 1  
 
 
 
± 2  
 
 
Cli nical Visit Da y  
X  
X  
X  
X  
 
X  
 
 
 
X  
 
 
X  
 
 
 
X  
X  
X  
P K S a m pli n g Det ails  
M ulti ple P K sa m ple [ 1 ] 
 
 
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
Si n gle P K sa m ple [ 2 ] 
 
 
 
 
 
X  
 
 
 
X  
 
 
X  
 
 
 
 
X  
X  
Pr oce d ure  
I nf or me d c o nse nt [3 ] 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
I/ E criteria [4 ] 
X  
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
De m o gra p hics  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Me dical/s ur gical hist or y  
X  
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pri or a n d c o nc o mita nt 
me dicati o ns [ 5 ] 
X  
A d verse e ve nts [ 6 ] 
 
 
 
X  
C o m plete p h ysic al 
e xa mi n ati o n [ 7 ] 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
X  [8 ] 
Li mite d p h ysical 
e xa mi n ati o n [ 7 ] 
 
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Wei g ht a n d hei g ht [ 9 ] 
X  
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vital si g ns [ 1 0 ] 
X  
X  
X  
X  
 
X  
 
 
 
X  
 
 
X  
 
 
 
X  
X  
X  
Uri ne dr u g scree n  
X  
 
X  [1 2 ] 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
X  
Breat h alc o h ol test  
X  
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HI V/ H Bs A g/ H C V scree n  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
F S H [ 1 1 ] 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
T S H  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
P re g na nc y test [1 3 ] 
X  
X  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
X  [8 ] 
1 2 -lea d E C G [1 4 ]  
X  
 
X  
X  [1 5 ] 
 
X  
 
 
 
 
 
 
X  
 
 
 
X  [1 5 ] 
 
X  [8 ] 
G E B T  [1 6 ]  
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
X [ 8 ] 
See f o ot n otes at t he e n d of t h e t a ble o n t h e f oll o wi n g p a ge.  
 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
6 3  
T a ble 1 . Sc he d ule of Pr oce d ures  ( C o nti n ue d) 
St u d y D a y  
Scree ni n g  
B aseli ne  
G E B T  [1 6 ] 
R a n d o miz ati o n  
[2 1 ] 
Tre at me nt Peri o d  
F oll o w -
u p / E T 
-2 8  t o -8  
-7  t o -2  
-1  or 1  
1  
2  
3  
4  
5  
6  
7  
8  
9  
1 0  1 1  1 2  1 3  
1 4  
1 5  
1 6 t o 1 7  
Visit Wi n d o w ( D a ys)  
 
 
 
 
 
± 1  
 
 
 
± 1  
 
 
± 1  
 
 
 
± 2  
 
 
C he mistr y, he mat ol o g y, 
a n d c oa g ulati o n  
X  
 
X  
 
 
X  
 
 
 
X  
 
 
X  
 
 
 
X  
 
X [ 8 ] 
Pr olacti n  [1 8 ] 
X  
 
X  
X  
 
X  
 
 
 
X  
 
 
X  
 
 
 
X  
 
X [ 8 ] 
Uri nal ysis  
X  
 
X  
 
 
X  
 
 
 
X  
 
 
X  
 
 
 
X  
 
X [ 8 ]  
St u d y dr u g a d mi nistrati o n 
[1 9 ] 
 
 
 
X  
X  X  X  X  X  X  X  X  X  X  X  X  
X  
 
 
St u d y dr u g acc o u nta bilit y 
a n d c ollecti o n of u n use d 
st u d y dr u g  
 
 
 
 
 
X  
 
 
 
X  
 
 
X  
 
 
 
X  
 
 
P G x sa m ple ( o pti o nal) [ 2 0 ] 
X  
N ote: All da ys will be re p orte d as t h e ne xt n o mi n al da y i n se q ue ntial or der (ie, if t h e o ut p atie nt visit Da y 3 [ ± 1 Da y] ta kes place o n t he se q ue ntial Da y 4, it will be rec or de d as 
Da y 4. All f oll o wi n g da ys will be rec or de d li ke wise).  
1.  
O n Da y s 1 a n d 1 4  (± 2 da ys) , patie nt will be c o nfi n e d i n t h e cli nic 
; bl o o d sa m ples f or P K a nal ysis will be collecte d pri or t o t he m or ni n g d os e 
 a n d 
 after t he m or ni n g d ose. Bl o o d sa m ples f or P K a nal yses will als o 
be c ollecte d
 after t he fi n al dose o n Da y 1 4 ( ± 2 da ys ). T he f oll o wi n g wi n d o ws will be per mitte d f or t h e c ollecti o n of P K sa m ples: 
 
 
2.  
O n Da ys 3  (± 1 da y), 7 ( ± 1  da y), a n d 1 0  (± 1 da y) , patie nts will re p ort t o t he cli nic f or a n o ut p atie nt visit . B l o o d sa m ples f or P K a nal ysis will be ta ke n pri or t o t heir m or ni n g 
d ose of st u d y dr u g  ( wit hi n 5 mi n utes). O n Da ys 1 5 t o  1 7, bl o o d sa m ples f or P K a nal yses will als o be c ollecte d o ver 
 after t he fi n al d os e o n Da y  1 4  (± 2 da ys) . 
3.  
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 nt s b ef ore a n y st u d y pr oce d ures are perf or me d. 
4.  
Scree ni n g pr oce 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 h a n 2 ti mes f or  eli gi bilit y p ur p oses.   
5.  
A n y me dicati o ns a d mi nistere d 2 8 da ys pri or t o t h e first d ose of st u d y dr u g a n d d uri n g t h e st u d y peri o d m ust b e rec or de d.  Starti n g  o n Da y 1, c o nc o mita nt me dicati o ns will 
be rec or de d  b y t h e patie nt  pri or t o eac h d ose  a n d rec or de d b y t he I n vesti gat or at eac h o ut p atie nt visit pri or t o eac h d ose.  
6.  
A d verse e ve nts will be m o nit ore d a n d d oc u me nte d  b y t h e patie nt a n d b y t h e I n vesti gat or at eac h o ut patie nt visit  fr o m t h e ti me first d ose of st u d y dr u g u ntil st u d y 
partici p ati o n is c o m plete.  
7.  
A c o m plete p h ysic al e xa mi n ati o n will c o nsist of ge neral a p peara nce, 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. A li mite d p h ysical e xa mi n ati o n will c o nsist of a mi ni m u m of ge neral a p peara nce, s k i n, heart, l u n gs, a n d a b d o me n. 
8.  
St u d y pr oce d ure will be perf or me d at t he E T V isit o nl y. 
9.  
Hei g ht will be meas ure d at t h e Scree ni n g Visit o nl y. B o d y mass i n de x will be calc ulate d at t h e Scree ni n g Visit usi n g hei g ht a n d wei g ht c oll ecte d at t h e Scree ni n g Visit. At 
t h e ti me of ra n d o mizati o n ( Da y  -1  or Da y 1 ), B MI will be calc ulate d usi n g wei g ht fr o m t h e ti me of ra n d o mizati o n ( Da y  -1  or Da y 1 ) a n d hei g ht fr o m t h e Scree ni n g Visit.  
1 0.  Vital si g ns i ncl u de heart rate, bl o o d press ure, res pirati o n rate, a n d te m perat ure  a n d will be c ollecte d w hile patie nt is sitti n g after a mi ni m u m 5 -mi n ute rest . 
1 1.  F ollicle -sti m ulati n g h or m o ne will o nl y be meas ure d f or fe males w h o ha ve bee n p ost me n o pa usal f or at least 1 year a n d are n ot s ur gicall y  st erile. 
1 2.  At t h e ti me or ra n d o mizati o n ( Da y -1 or 1), a P O C dr u g test will be perf or me d.  
1 3.  A pre g na nc y test 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 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 h e Scree ni n g Visit]). A ser u m pre g na nc y t est will be perf or me d o n Da ys -2 8 t o -8, Da ys -7 t o -2 , a n d Da y 1 4 ( ± 2 da ys ). A P O C pre g na nc y test will be perf or me d o n 
Ra n d o mizati o n Da y.  

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
6 4  
1 4.  All 1 2 -lea d E C Gs will be perf or me d i n tri plicate a p pr o xi matel y 1 mi n ute a part after t he patie nt  has b ee n resti n g i n t h e s u pi ne p ositi o n f or at least 1 0 mi n utes. T wel ve-lea d 
E C Gs f or safet y a nal ys es 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 a n I n vesti gat or ( or S u bi n vesti gat or f or Scree ni n g Visit o nl y) . 
1 5.  O n Da ys 1 a n d 1 4  (±  da ys ), E C Gs will be perf or me d at t h e f oll o wi n g ti mes: 
 
1 6.  P atie nts will ha ve baseli ne G E B T p erf or me d bet wee n Da y s -7  a n d -1  after a mi ni m u m 1 4 -da y was h o ut fr o m m otilit y a ge nts  a n d st u d y G E B T perf or me d  o n 
Da y  1 4  (± 2  da ys ) 3 0 mi n utes after st u d y dr u g a d mi nistrati o n.  Breat h sa m ples will be 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 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 meal c o ns u m pt i o n after a 6 -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 ). Fasti n g gl u c ose will be assess e d bef ore G E B T t o e ns ure a bl o o d gl u c ose le vel of  2 7 5 m g/ d L.  
1 7.  
 
 
1 8.  Sa m ple c ollecte d pre d ose.  
1 9.  All patie nt s 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 
 
P atie 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 after t he m or ni n g d ose o n t he da ys w he n t h e G E B T a n d 
serial P K dra ws will be perf or me d (Da ys 1 a n d 1 4  [± 2 da ys]) . 
. D uri n g c o nfi n e 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 site b y site staff . P atie nts will be pr o vi d e d st u d y dr u g f or self-a d mi nistrati o n f or st u d y da ys n ot at t h e site. 
2 0.  F or patie nts w h o pr o vi d e writte n i nf or me d c o nse nt t o partici p ate i n t h e o pti o nal P G x assess me 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 p ati o n i n t he st u d y.  
2 1.  Ra n d o mizati o n pr oce d ures ma y occ ur o n Da y 1 if l o cal la b orat or y r es ults ca n be o btai ne d t o c o nfir m eli gi bilit y pri or t o d osi n g. I n t his i nsta nce, bl o o d a n d uri n e sa m ples f or 
cli nical safet y la b orat or y tests will als o still be se nt t o t he ce ntral la b orat or y f or a nal ysis. 
 B MI = b o d y mass i n de x; 
E C G  =  ele ctr o car di o gra m; E T = e arl y ter mi n ati o n; F S H = f ollicle -sti m ulati n g h or m o ne; G E B T = gastric e m pt yi n g breat h test; 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/ E  =  i n cl usi o n a n d e xcl usi o n; 
 
P O C  = p oi nt of care, Se verit y I n de x ; P K  =  p har mac o ki n etic; P G x  =  p har mac o ge n o mic ; T S H = t h yr oi d-sti m ulati n g h or m o ne. 
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
6 5  
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 nsf eras 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 ne ki nase  
Creati ni ne  
Esti mate d gl o mer ular filtrati o n rate 
Ga m ma -gl uta m yl tra nsf erase  
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 ollicle -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 ollicle -sti m ulati n g h or m o ne will o nl y be assesse d i n fe males w h o h a ve bee n 
p ost me n o pa usal f or at least 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  
Re 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 pecific 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 pstic k res ults.  
 

Ci n D o me P har ma, I nc. 
Cli nical St u d y Pr ot oc ol CI N -1 0 2 -1 2 1  
C o nfi de ntial & Pr o prietar y  
 
Versi o n 1. 0, 1 9  Ma y 2 0 1 9  
6 6  
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 t est s will o nl y be perf or me d i n fe m ales w h o are n ot 
s ur gic all 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]). 
 
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 care dr u g test o n ra n d o mizati o n da y.  
 
Bre at h Alc o h ol Test