Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being
tested to find a safe and well-tolerated dose and to assess how dexlansoprazole is processed
by the body in infants aged 1 to 11 months. This study will look at side effects and lab
results in infants who take dexlansoprazole.

The study will enroll approximately 24 participants. Participants will be randomly assigned
to 1 of the 4 treatment groups based on body weight and age:

- Dexlansoprazole 10 mg

- Dexlansoprazole 15 mg

- Dexlansoprazole 20 mg

- Dexlansoprazole 30 mg

Participants who weigh <3.4 kg will not be enrolled. Participants ≤ 10 weeks of age with a
body weight of ≥ 3.4 kg will initially receive Regimen A (dexlansoprazole delayed-release 10
mg capsules). Randomization for participants > 10 weeks of age will be stratified by weight
group. Participants whose baseline weight is ≥ 3.4 kg but < 4.1 kg will be assigned to
receive Regimen A or Regimen B (dexlansoprazole delayed-release 10 or 15 mg capsules as an
initial dose) in a ratio of 1:1. Participants whose weight is ≥ 4.1 kg but < 6.2 kg will be
assigned to receive Regimens B or C (dexlansoprazole delayed-release 15 or 20 mg capsules as
an initial dose) in a ratio of 1:1. Participants whose weight is ≥ 6.2 kg will be assigned to
receive Regimen B, C, or D (dexlansoprazole delayed-release 15, 20, or 30 mg capsules as an
initial dose) in a ratio of 1:1:2.

All participants will be administered 1 capsule of dexlansoprazole in the morning at the same
time each day throughout the study. The study medication may be administered to the
participants by opening a capsule and sprinkling the granules on 1 tablespoon of applesauce
or pureed apples, or mixing the capsule granules with about 20 mL of water. The food-granule
mixture should be administered immediately. The water mixed with the granules will be
administered via an oral syringe into the mouth immediately. The granules should not be
chewed in mouth. The food or liquid used for administering the study medication should be
recorded for Days 1 through Confinement Day 1. The parents of all participants will be asked
to record dosing information, the food or liquid used for administering the study medication
(Day 1 through Confinement Day 1), food intake, and episodes of vomiting in a diary from Day
2 until the day before Confinement Day 1 (Day 5 to 9).

This multicenter trial will be conducted worldwide. The overall time to participate in this
study is up to 114 days. Participants will make multiple visits to the clinic, including two
2-day visits that may require confinement to the clinic, and will be contacted by telephone
30 days after last dose of study drug for a follow-up assessment.

Inclusion Criteria:

1. Prior to any study-specific procedures being performed and after having the study
fully explained and all questions answered, the informed consent form (ICF) must be
signed and dated by parent(s) or legal guardian(s). The Screening Period starts at the
time of consent.

2. Is a male or female infant 1 to 11 months old, inclusive, on Day 1. Infants who were
born prematurely must be ≥ 45 weeks old based on corrected gestational age.

3. At the Initial Screening and Day -1 visits, participant must have body weight
percentile-for-age within the 5th through 95th percentile by age, inclusive, as
determined by the World Health Organization (WHO) growth chart.

4. Must be ≥ 3.4 kg at the Screening and Day -1 visits.

5. Participants who take a prescription or nonprescription proton pump inhibitor (PPI),
histamine-2 receptor antagonists(H2RA), sucralfate, or antacids on a regular or as
required basis must agree to discontinue use at Day -1 (except cimetidine, which must
be discontinued 28 days prior to Day -1) or other acid suppression therapy, and agree
to discontinue use throughout the study.

6. Must have endoscopically proven erosive esophagitis (EE), a history of EE, and/or 1 or
more of the following underlying conditions that predispose the participant to chronic
gastroesophageal reflux disease (GERD) and EE: moderate to severe neurologic
impairment, repaired esophageal atresia, hiatal hernia, cystic fibrosis,
bronchopulmonary dysplasia, or end-stage renal disease.

7. Except for participants with EE, a history of EE, or repaired esophageal atresia,
participants have:

- Received prior PPI therapy or other acid suppression therapy for a minimum of 2
weeks during any time in the past with symptomatic response and have demonstrated
a recurrence of symptoms following at least 1 attempted withdrawal of PPI therapy
or other acid suppression therapy AND

- Have undergone esophageal pH monitoring in the recent past to document that their
symptoms are due to acid-mediated disease.

8. Must be able to ingest study medication granules sprinkled on 1 tablespoon of
applesauce or pureed apples, or as a mixture of granules in water administered via an
oral syringe.

9. Must be at least 7 days post-surgery by dosing on Day 1 and have no anticipated need
for surgery during the study.

10. Screening laboratory samples must be collected Day -7 to Day -2) and the results must
be within the range expected for this infant population (except gastrin results as
those results will be available after Day 1). The laboratory results should indicate
no clinically significant (CS) abnormality in chemistry (including electrolytes, blood
urea nitrogen [BUN]), creatinine, glucose, alanine aminotransferase (ALT), aspartate
aminotransferase (AST), and total bilirubin), hematology (complete blood cell count,
including differential), and urinalysis parameters (if standard of care).

Exclusion Criteria:

1. Has evidence of cardiovascular, pulmonary, central nervous system, hepatic,
hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or serious
allergy, asthma, or allergic skin rash that suggests clinically significant,
uncontrolled underlying disease or condition (other than the disease being studied
and/or identified as the main criterion for inclusion), that may impact the ability of
the participant to participate or potentially may confound the study results.

2. Has known history of or current presence of peptic ulcers or gastrointestinal bleeding
(hematemesis, hematochezia).

3. Has poor venous access or any contraindication to blood sampling.

4. Has known history of eosinophilic gastroenteropathy, or a coexisting disease affecting
the esophagus, including esophageal varices, viral or fungal infection, or esophageal
stricture, history of radiation therapy or cryotherapy to the esophagus, and caustic
or physiochemical trauma such as sclerotherapy to the esophagus.

5. Has active malabsorption syndrome, cow's milk intolerance, milk protein allergy, or
celiac disease.

6. Has any finding in his/her medical history, physical examination, or safety clinical
laboratory tests giving reasonable suspicion of a disease that might interfere with
the conduct of the study or that would contraindicate taking dexlansoprazole
delayed-release capsules or a similar drug in the same class (ie, a PPI).

7. Has a known hypersensitivity to any PPI or any component of the formulation of
dexlansoprazole delayed-release capsules.

8. Is required to take excluded medications or it is anticipated that the participant
will require treatment with at least 1 of the disallowed concomitant medications
during the study evaluation period.

9. Has a history of malignant disease.

10. Has a known history of infection with the human immunodeficiency virus.

11. Has lost > 10% of the total blood volume, undergone plasmapheresis, or has had a
transfusion of any blood product within 90 days prior to the first dose of study
medication.

12. Has consumed Excluded Medications and Dietary Products during the time periods listed,
or parent(s) or legal guardian(s) is unwilling to agree to participant abstaining from
products while participating in the study.

13. Has participated in a study of an investigational agent (including dosing or
follow-up) within 30 days prior to Screening.

14. Has a Screening Visit laboratory value that the principal investigator and sponsor
consider to be clinically significant.

15. Has creatinine > 1.5 mg/dL, ALT and/or AST > 2 times the upper limit of normal (ULN),
or total bilirubin > 2.0 mg/dL with AST/ALT elevated above the limits of normal
values.

16. The participant or parent/legal guardian is an immediate family member, study site
employee, or is in a dependent relationship with a study site employee who is involved
in the conduct of this study or may consent under duress.

17. Parent/legal guardian, in the opinion of the investigator, is unlikely to comply with
the protocol or is unsuitable for any other reason.

18. Has any congenital anomaly of the upper gastric intestinal tract that might interfere
with gastrointestinal motility, pH, or absorption, or has an active or known history
of necrotizing enterocolitis that has been surgically corrected.

19. Has clinical evidence of acute sepsis. Infants on chronic antibiotics who are
otherwise clinically stable may be enrolled in the study at the discretion of the
investigator.

20. Has received a vaccine within 48 hours prior to dosing on Day 1.

21. Has used intravenous or oral antifungal agents within the 7 days prior to Day -1.

22. Has used mucosal protective agent (eg, sucralfate) within 6 hours prior to dosing on
Day 1.