Phase 1
Completed N=36
Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease
Source: ClinicalTrials.gov NCT01045096 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Apr 2012
Primary outcomePrimary: Time to Reach the Peak Plasma Concentration (Tmax) — 4.4; 4.1; 4.1 hours — p=0.809
Summary
The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Reach the Peak Plasma Concentration (Tmax) |
4.4; 4.1; 4.1 | 0.809 |
| PRIMARY The Peak Plasma Concentration (Cmax) |
559; 1005; 964 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)) |
1914; 2892; 3747 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)) |
2149; 2628; 3330 | — |
Eligibility Criteria
Inclusion Criteria
- Must have a body weight within the 5th through 95th percentile by age, inclusive, as determined by the National Center for Health Statistics .
- Females of childbearing potential must not be nursing, must have a negative serum pregnancy test at the Screening Visit and on Day -1, and if sexually active agree to routinely use adequate contraception from Screening and throughout the duration of the study.
- Subjects who take prescription or non-prescription proton pump inhibitors (PPI), histamine receptor antagonists (except cimetidine), sucralfate, or antacids on a regular or as required basis must agree to discontinue usage on Day -1 and agree to discontinue use throughout the study.
- Must have a history of GERD symptoms for at least 2 months prior to Screening or is currently symptomatic, as determined by the investigator.
- Must be able to swallow study drug capsule or must be able to ingest study drug granules sprinkled on 1 tablespoon of applesauce.
Exclusion Criteria
- Has evidence of current cardiovascular, central nervous system, pulmonary, endocrine disease, hepatic, hematopoietic, renal, or metabolic dysfunction, serious allergy, asthma, or allergic skin rash.
- Has a known hypersensitivity to any PPI or any component of the formulation of dexlansoprazole capsules.
- Is taking any other prescription (except birth control) or nonprescription medication (including cimetidine), vitamins, or dietary supplements within 10 days prior to Day 1, or has taken herbal over-the-counter medications within 28 days prior to Day 1.
- Has a positive test result for hepatitis B surface antigen or hepatitis C virus antibody.
- Has donated or lost greater than 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 drug.
- Has a history of alcohol abuse or illegal drug use or drug abuse in the past, or tests positive for alcohol or drugs of abuse at the initial Screening Visit or Day -1 or is unwilling to agree to abstain from alcohol and drugs throughout the study.
- Has used a product containing nicotine within 90 days prior to the first dose of study drug or has a positive cotinine screen at the initial Screening Visit or Day -1 or is unwilling to agree to abstain throughout the study.
- Is determined to be a Cytochrome P450 2C19 poor metabolizer (ie, genotyped homozygous non-wild-type).
Data sourced from ClinicalTrials.gov (NCT01045096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.