PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects

• ClinicalTrials.gov Identifier: NCT02401035
• Recruitment Status: Recruiting
• First Posted: March 27, 2015
• Last Update Posted: September 16, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: December 15, 2014
• First Posted Date: March 27, 2015
• Last Update Posted Date: September 16, 2021
• Actual Study Start Date: May 9, 2017
• Estimated Primary Completion Date: April 20, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 27, 2018)

• Volume of distribution of IV pantoprazole [ Time Frame: Day 1 ]
  Pharmacokinetic parameters will be summarized descriptively
• Clearance of IV pantoprazole [ Time Frame: Day 1 ]
  Pharmacokinetic parameters will be summarized descriptively
• Volume of distribution of IV pantoprazole [ Time Frame: Day 2 ]
  Pharmacokinetic parameters will be summarized descriptively
• Clearance of IV pantoprazole [ Time Frame: Day 2 ]
  Pharmacokinetic parameters will be summarized descriptively

Original Primary Outcome Measures (submitted: March 23, 2015)

• time to peak plasma concentration (Tmax) of iv pantoprazole [ Time Frame: Day 1 ]
  Pharmacokinetics parameters will be summarized descriptively
• peak plasma concentration (Cmax) of iv pantoprazole [ Time Frame: Day 1 ]
  Pharmacokinetics parameters will be summarized descriptively
• area under the concentration-time curve from time zero to last concentration (AUClast) of iv pantoprazole [ Time Frame: Day 1 ]
  Pharmacokinetics parameters will be summarized descriptively
• area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) of iv pantoprazole [ Time Frame: Day 1 ]
  Pharmacokinetics parameters will be summarized descriptively
• steady state volume of distribution (Vss) of iv pantoprazole [ Time Frame: Day 1 ]
  Pharmacokinetics parameters will be summarized descriptively
• terminal phase half-life (T1/2) of iv pantoprazole [ Time Frame: Day 1 ]
  Pharmacokinetics parameters will be summarized descriptively
• clearance (CL) of iv pantoprazole [ Time Frame: Day 1 ]
  Pharmacokinetics parameters will be summarized descriptively
• time to peak plasma concentration (Tmax) of iv pantoprazole [ Time Frame: Day 7 ]
  Pharmacokinetics parameters will be summarized descriptively
• peak plasma concentration (Cmax) of iv pantoprazole [ Time Frame: Day 7 ]
  Pharmacokinetics parameters will be summarized descriptively
• area under the concentration-time curve from time zero to last concentration (AUClast) of iv pantoprazole [ Time Frame: Day 7 ]
  Pharmacokinetics parameters will be summarized descriptively
• terminal phase half-life (T1/2) of iv pantoprazole [ Time Frame: Day 7 ]
  Pharmacokinetics parameters will be summarized descriptively
• clearance (CL) of iv pantoprazole [ Time Frame: Day 7 ]
  Pharmacokinetics parameters will be summarized descriptively

Current Secondary Outcome Measures (submitted: December 27, 2018)

• CYP2C19 genotyping [ Time Frame: Day 1 ]
  CYP2C19 genotyping will be summarized descriptively
• Maximum Plasma Concentration [ Time Frame: Day 1 ]
  Pharmacokinetic parameters will be summarized descriptively
• Maximum Plasma Concentration [ Time Frame: Day 2 ]
  Pharmacokinetic parameters will be summarized descriptively
• Area under plasma concentration-time profile from 0 to 24 hours [ Time Frame: Day 1 ]
  Pharmacokinetic parameters will be summarized descriptively
• Area under plasma concentration-time profile from 0 to 24 hours [ Time Frame: Day 2 ]
  Pharmacokinetic parameters will be summarized descriptively
• Area under plasma concentration-time profile from time 0 extrapolated to infinite time [ Time Frame: Day 1 ]
  Pharmacokinetic parameters will be summarized descriptively
• Area under plasma concentration-time profile from time 0 extrapolated to infinite time [ Time Frame: Day 2 ]
  Pharmacokinetic parameters will be summarized descriptively
• Terminal half-life [ Time Frame: Day 1 ]
  Pharmacokinetic parameters will be summarized descriptively
• Terminal half-life [ Time Frame: Day 2 ]
  Pharmacokinetic parameters will be summarized descriptively

Original Secondary Outcome Measures (submitted: March 23, 2015)

CYP2C19 genotyping [ Time Frame: Day 1 ]

CYP2C19 genotyping will be summarized descriptively

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
• Official Title: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE PHARMACOKINETICS OF SINGLE AND MULTIPLE INTRAVENOUS DOSES OF PANTOPRAZOLE IN TWO AGE COHORTS OF HOSPITALIZED PEDIATRIC SUBJECTS 1 TO 16 YEARS OF AGE WHO ARE CANDIDATES FOR ACID SUPPRESSION THERAPY
• Brief Summary: The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.

Detailed Description

In hospitalized pediatric subjects, age 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy, the following are the objectives of this trial:

Primary Objectives To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 1 to less than 2 years old.

To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 2 to 16 years old.

Secondary Objectives To determine the safety, tolerability, and PK of single and multiple IV doses of pantoprazole in each of the independent age cohorts.

To assess the CYP2C19 genotype in pediatric subjects receiving IV pantoprazole, to determine the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastroesophageal Reflux Disease

Intervention

Drug: IV pantoprazole

Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight

Study Arms

Experimental: IV pantoprazole

Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight.

Intervention: Drug: IV pantoprazole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 23, 2015): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 18, 2027
• Estimated Primary Completion Date: April 20, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subjects aged 1 to 16 years who in the judgment of the investigator are candidates for gastric acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD) and whom the investigator judges would need to receive IV PPI therapy for at least 4 days.
• Body weight > 5th percentile for age.
• Y-site or dedicated IV line for administration of pantoprazole sodium.
• Expected survival for at least 30 days.
• Fertile male and female subjects of childbearing potential at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Female subjects of non-childbearing potential must be premenarchal, have undergone hysterectomy with bilateral oophorectomy, have medically confirmed ovarian failure, or achieved post-menopausal status.

Exclusion Criteria:

• Participation in other studies involving investigational drug(s) or treatment with an investigational drug within 30 days or 5 half lives prior to study entry and/or during study participation.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Pregnant females; breastfeeding females; fertile male subjects, and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after last dose of investigational product.
• Serum CK levels >3x ULN.
• Known history of HIV or clinical manifestations of AIDS.
• Known hypersensitivity to PPIs or to any substituted benzimidazole or to any of the excipients.
• History of treatment with any PPI within 2 days (48 hours) before investigational product dosing on Day 1.
• Use of H2RAs, sucralfate, misoprostol, or prokinetic agents, and bismuth preparations within 1 day (24 hours) before investigational product dosing on Day 1.
• Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin, methotrexate, atazanavir or nelfinavir, clopidogrel, and potent inhibitors and inducers of CYP2C19.
• Chronic (daily) use of glucocorticoids. Steroid inhalers and topical steroids may be used.
• Active malignancy of any type, or history of a malignancy (Subject with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable).
• ALT or BUN >2.0 ULN or estimated creatinine >1.5 X ULN for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before Screening.
• In the Investigator's opinion, a chronic condition (eg, diabetes, epilepsy), which is either not stable or well controlled and may interfere with the conduct of the study.
• History of sensitivity to heparin or heparin induced thrombocytopenia.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 16 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

• Listed Location Countries: Argentina, Bosnia and Herzegovina, Georgia, Germany, Italy, Puerto Rico, Serbia, Slovakia, Ukraine, United States
• Removed Location Countries: Spain

Administrative Information

• NCT Number: NCT02401035
• Other Study ID Numbers: B1791089; 2014-002182-29 ( EudraCT Number ); B1791089 ( Other Identifier: Study Number ); GERD ( Other Identifier: Alias Study Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: September 2021