Pediatric Gastroesophageal Reflux Disease Clinical Trial
Official title:
A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases
The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) [after daily administration for 7 days] and safety [after daily administration for 8 weeks] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.
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.
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