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A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease

NCT05343364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-04-23

Study results available
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Summary

The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan in adolescent participants with symptomatic gastroesophageal reflux disease (GERD).

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

Vonoprazan

Oral Tablet

Sponsors & Collaborators

  • Phathom Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Phathom Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2023-05-30
Completion
2023-06-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05343364 on ClinicalTrials.gov