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Stopped: Withdrawn: Business decision (no enrollment)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 States0Started 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 range1 Month – 11 Months

SexALL

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

Exclusion criteria

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

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 range1 Month – 11 Months

SexALL

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