A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease (NCT06106022) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease
United States22 participantsStarted 2023-11-01
Plain-language summary
The aim of this study is to evaluate the pharmacokinetic (PK) profile of vonoprazan (10 or 20 mg once daily \[QD\]) in children ≥ 6 to \< 12 years of age who have symptomatic Gastroesophageal Reflux Disease (GERD).
Who can participate
Age range6 Years – 11 Years
SexALL
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Inclusion criteria
✓. The participant has a body weight within the 5th through 95th percentile by age, inclusive, as determined by the National Center for Health Statistics.
✓. The participant must have a diagnosis of GERD prior to randomization and medical history of signs or symptoms of GERD for at least 3 months prior to screening, based on physical examination, current symptoms (eg, heartburn), or diagnostic tests (eg, pH or endoscopy). Notes in the medical records and/or other source documents, such as prior endoscopies, can be used to support the diagnosis and will be recorded in the electronic case report form (eCRF).
✓. The participant has at least one moderate GERD symptom based on the GERD Symptom Assessment Investigator scale performed at screening.
✓. The participant must be able to swallow study drug tablet with water.
✓. Parent or legal guardian (ie, legally authorized representative \[LAR\]) is willing and able to complete the informed consent process and participants are able to comply with study procedures and visit schedule.
✓. Female participants who have experienced menarche must have a negative pregnancy test and will be counseled on pregnancy avoidance.
Exclusion criteria
✕. The participant has used prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonist (H2RAs) within 7 days prior to randomization or requires use during the Treatment Period.
✕. The participant has used sucralfate, or antacids within 1 day prior to randomization or requires their use during the Treatment Period.
What they're measuring
1
Maximum Drug Concentration at Steady-state (Cmax,ss) of Vonoprazan
Timeframe: Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
2
Area Under the Plasma Concentration-time Curve During the Dosing Interval Ï„ at Steady State (AUCÏ„,ss) of Vonoprazan
Timeframe: Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
3
Apparent Oral Clearance (CL/F) at Steady State of Vonoprazan
Timeframe: Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
4
Apparent Central Volume of Distribution (Vz/F) at Steady State of Vonoprazan
Timeframe: Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
. The participant has received other agents affecting digestive organs, including muscarinic antagonists (eg, hyoscyamine), prokinetics, oral anticholinergic agents, prostaglandins, bismuth from 30 days prior to Day 1 or requires their use during the course of the study.
✕. The participant has received atazanavir sulfate or rilpivirine hydrochloride from 5 days prior to Day 1 or requires their use during the course of the study.
✕. The participant has received any investigational compound (including vonoprazan) within 30 days prior to the start of the Screening Period.
✕. The participant is an immediate family member or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, child, sibling) or participant may have consented under duress.
✕. The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Period.
✕. The participant has undergone prior gastrointestinal surgeries.