Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease - Full Text View

Sponsor:	Takeda Global Research & Development Center, Inc.
Information provided by (Responsible Party):	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00847210

Purpose

The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: Dexlansoprazole MR	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents With Symptomatic Gastroesophageal Reflux Disease

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders GERD

Drug Information available for: Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter [ Time Frame: After 7 days of dosing. ] [ Designated as safety issue: No ]
Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ] [ Designated as safety issue: No ]
Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ] [ Designated as safety issue: No ]
Area Under the Plasma Concentration Versus Time Curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ] [ Designated as safety issue: No ]
AUC(0-24) is measure of Area Under the Curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 24 hours in this study).
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ] [ Designated as safety issue: No ]
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Oral Clearance (CL/F) Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ] [ Designated as safety issue: No ]
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.
Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ] [ Designated as safety issue: No ]
Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.
Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ] [ Designated as safety issue: No ]
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.

Enrollment:	36
Study Start Date:	May 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dexlansoprazole MR 30 mg QD	Drug: Dexlansoprazole MR Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days. Other Names: TAK-390MR Kapidex Dexilant
Experimental: Dexlansoprazole MR 60 mg QD	Drug: Dexlansoprazole MR Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days. Other Names: TAK-390MR Kapidex Dexilant

Detailed Description:

Gastroesophageal reflux disease is a condition of multifactorial etiology resulting in the reflux of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of Gastroesophageal reflux disease in the pediatric population is becoming increasingly recognized and documented. It is a chronic disease that can persist through adulthood with symptoms in older children and adolescents being similar to those seen in adults. The prevalence of gastroesophageal reflux disease increases with age, from 2.5% of children between the ages of 3 and 9 years, to 8.5% of those between the ages of 10 and 17 years.

Younger children generally present with extra-esophageal manifestations, regurgitation, and epigastric pain, while older children and adolescents typically present with adult-type gastroesophageal reflux disease symptoms of heartburn and regurgitation. Treatment for gastroesophageal reflux disease is aimed at alleviating symptoms and healing the esophageal inflammation.

This study evaluated the pharmacokinetics and safety of dexlansoprazole MR in the pediatric population (ages 12-17) and determined if the pharmacokinetic profile is similar to that in adults given the same dose.

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Body weight is greater than or equal to 30 kg.
Females of childbearing potential who are sexually active must agree to use an acceptable form of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Must have an estimated creatinine clearance greater than or equal to 80 mL/minute as determined from the Cockcroft-Gault formula.
Participants who take prescription or non-prescription proton pump inhibitors, histamine receptor antagonists (except cimetidine), sucralfate, or antacids on a regular or as required basis must agree to discontinue usage throughout the study.
Must have a history of gastroesophageal reflux disease symptoms, as documented by a physician, for at least 2 months prior to Screening or is currently symptomatic.
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, hepatic, hematopoietic, renal, or metabolic dysfunction, serious allergy, asthma, or allergic skin rash.
Has any finding in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of a disease that might interfere with the conduct of the trial or that would contraindicate taking dexlansoprazole MR or a similar drug in the same class.
Has a known hypersensitivity to any proton pump inhibitors or any component of the formulation of dexlansoprazole MR (see most current version of the Investigator Brochures).
Has a history of malignant disease.
Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody.
Has a known history of infection with the human immunodeficiency virus.
Has donated or lost greater than or equal to 300 mL blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
Is required to take or intends to continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
Has consumed grapefruit or grapefruit juice within 14 days prior to the first dose of study drug or is unwilling to agree to abstain from grapefruit or grapefruit juice while participating in the study.
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.
Has participated in a study of an investigational agent (including dosing or follow up) within 30 days prior to first dose of study drug.
Has an initial Screening Visit or Day -1 laboratory value that the principal investigator considers to be clinically significant.
Participant is determined to be a CYP2C19 isozyme poor metabolizer (ie, genotyped homozygous non-wild type).
Is unlikely to comply with the protocol or is unsuitable for any other reason per the opinion of the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847210

Locations

United States, California

Anaheim, California, United States

Cypress, California, United States
United States, Kansas

Overland Park, Kansas, United States

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Medical Director Pharmacovigilance

Takeda Global Research & Development Center, Inc.

More Information

Additional Information:

Dexilant Package Insert This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Publications:

Kukulka M, Wu J, Perez MC. Pharmacokinetics and Safety of Dexlansoprazole MR in Adolescents With Symptomatic GERD. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):41-7.

Responsible Party:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00847210 History of Changes
Other Study ID Numbers:	T-P107-163, U1111-1114-1891
Study First Received:	February 18, 2009
Results First Received:	September 8, 2010
Last Updated:	January 31, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Esophageal Reflux
Gastro-Esophageal Reflux
Gastroesophageal Reflux Disease
GERD

Regurgitation, Gastric
Heartburn
Drug Therapy
Adolescent

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012