CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Vonoprazandrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06106022
NCT06106022Phase 1Completed
CompareCT.gov

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

Phathom Pharmaceuticals, Inc.·interventional·Posted Oct 30, 2023·Updated Dec 19, 2024

In Brief

A Phase 1 clinical trial evaluating Vonoprazan for Gastroesophageal Reflux Disease. Completed, enrolled 22 participants across 13 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedOct 30, 2023
Enrollment StartNov 1, 2023
Primary CompletionApr 16, 2024
Study CompletionApr 29, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.7 years ago

Interventions

Vonoprazandrug

Administered orally