NCT06106022

A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease

A Phase 1, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan (10 or 20 mg Once Daily) in Children Aged ≥ 6 to < 12 Years Who Have Symptomatic Gastroesophageal Reflux Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Phathom Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Vonoprazan	Administered orally

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-04-16
• Completion: 2024-04-29
• First posted: 2023-10-30
• Last updated: 2024-12-19
• Results posted: 2024-12-19

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study