Overview

PK Study With Pantoprazole in Obese Children and Adolescents

Status:
Completed

Trial end date:
2015-09-13

Target enrollment:
0

Participant gender:
All

Summary

Multicenter, comparative single-dose pharmacokinetic (PK) study

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Phillip Brian Smith

Collaborators:

The Emmes Company, LLC
The EMMES Corporation

Treatments:

Pantoprazole

Criteria

Inclusion Criteria:

1. Participant is between 6 and 17 (inclusive) years of age at the time of consent

2. BMI ≥95th percentile

3. Diagnosis of GERD established prior to 7 days before receipt of study drug dose
defined as 1 or more of the following:

1. clinical symptoms consistent with GERD as determined by the investigator

2. a diagnosis of erosive esophagitis by endoscopy

3. esophageal biopsy with histopathology consistent with reflux esophagitis

4. abnormal pH-metry consistent with reflux esophagitis

5. other test result consistent with GERD

4. 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:

1. Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48
hours prior to dose of study drug

2. 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

3. Consumption of food after midnight on the day of the baseline visit

4. Symptomatic asthma

5. Type I diabetes

6. History of adverse reaction to PPI

7. 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

8. Serum creatinine ≥2.0 mg/dL

9. For females of childbearing potential, a positive pregnancy test result

10. Known infection with hepatitis B, C, or HIV

11. Any other condition that, in the opinion of the principal investigator, makes
participation unadvised or unsafe.