Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease

NCT01045096 | Completed Phase 1 Results

• 2 other identifiers: T-P107-174U1111-1112-1684
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux; Erosive Esophagitis; Pharmacokinetics; Pediatrics; Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Time to Reach the Peak Plasma Concentration (Tmax)

  Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

  Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

• The Peak Plasma Concentration (Cmax)

  Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

  Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

• Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))

  AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

  Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

• Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))

  AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.

  Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Other Outcomes (3)

• Dose-normalized Peak Plasma Concentration (Cmax/Dose)

  Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

• Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)/Dose)

  Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

• Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)

  Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Study Arms (3)

Dexlansoprazole 15 mg QD

EXPERIMENTAL

Drug: Dexlansoprazole

Dexlansoprazole 30 mg QD

EXPERIMENTAL

Drug: Dexlansoprazole

Dexlansoprazole 60 mg QD

EXPERIMENTAL

Drug: Dexlansoprazole

Interventions

Dexlansoprazole DRUG

Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.

Also known as: Kapidex, TAK-390MR, Dexilant

Dexlansoprazole 15 mg QD

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

Miami Garden, Florida, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Related Links

• Dexilant Package Insert

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Dexlansoprazole; Lansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director, Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 8, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 5, 2012
• Results First Posted: April 5, 2012

Record last verified: 2012-03

Locations

US (4)