Phase 1 N=41 Basic Science

PK Study With Pantoprazole in Obese Children and Adolescents

Gastroesophageal Reflux Disease

Bottom Line

View on ClinicalTrials.gov: NCT02186652 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax). — 4.27; 4.1 mcg/ml

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Pantoprazole (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Phillip Brian Smith
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).	4.27; 4.1	—
PRIMARY Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).	2.3; 2.5	—
PRIMARY PK Sampling	11; 11	—
PRIMARY Drug Concentration in Plasma Samples	1558; 1626.1; 94.7; 88.7	—
PRIMARY Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).	5.73; 6.82	—
PRIMARY Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).	5.73; 6.82	—
PRIMARY Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).	0.14; 0.10	—
PRIMARY Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).	0.25; 0.25	—
PRIMARY Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).	0.25; 0.25	—
SECONDARY The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype	1.29; 6.00; 8.97	—

Summary

Multicenter, comparative single-dose pharmacokinetic (PK) study

Eligibility Criteria

Inclusion Criteria

Participant is between 6 and 17 (inclusive) years of age at the time of consent
BMI ≥95th percentile
Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:
clinical symptoms consistent with GERD as determined by the investigator
a diagnosis of erosive esophagitis by endoscopy
esophageal biopsy with histopathology consistent with reflux esophagitis
abnormal pH-metry consistent with reflux esophagitis
other test result consistent with GERD
Written informed consent from the parent or legally authorized representative/guardian and participant assent per local IRB recommendation of age-appropriate consent and assent requirements

Exclusion Criteria

Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate, valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within seven days prior to dose of study drug
Consumption of food after midnight on the day of the baseline visit
Symptomatic asthma
Type I diabetes
History of adverse reaction to PPI
Impaired hepatic activity as defined as any of the following: AST ≥150 IU/L, ALT ≥150 IU/L, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 IU/L
Serum creatinine ≥2.0 mg/dL
For females of childbearing potential, a positive pregnancy test result
Known infection with hepatitis B, C, or HIV
Any other condition that, in the opinion of the principal investigator, makes participation unadvised or unsafe.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02186652). 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.