WithdrawnPhase 1

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

Stopped: Withdrawn: Business decision (no enrollment)

United States, Israel, Italy0Started 2025-06-15

Plain-language summary

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.

Who can participate

Age range

1 Month – 11 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Observed Plasma Concentration (Cmax) of Dexlansoprazole

Timeframe: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose

Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUCt) of Dexlansoprazole

Timeframe: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose

Area Under the Plasma Concentration-Time Curve From Time 0 to Time tau [AUCtau)] for Dexlansoprazole

Timeframe: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose

Dose Normalized Maximum Observed Plasma Concentration (Cmax/dose) of Dexlansoprazole

Timeframe: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose

Dose Normalized Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUCt/dose) of Dexlansoprazole

Timeframe: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose

Trial details

NCT IDNCT02442752

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-23

View on ClinicalTrials.gov More Pediatric Gastroesophageal Reflux Disease trials

Who can participate

Age range

1 Month – 11 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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