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Proton Pump Inhibitor

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

Phase 1
Waitlist Available
Research Sponsored by Phathom Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood samples were collected predose, once between 0.5 and 2 hours, and once between 2.5 and 4 hours post-dose on days 7 and 14
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing vonoprazan, a drug that reduces stomach acid, in teenagers who have GERD. GERD causes discomfort due to excess stomach acid. Vonoprazan works by blocking pumps in the stomach that produce acid, helping to relieve symptoms like heartburn. Vonoprazan has shown greater ability to suppress gastric acid production compared to conventional treatments.

Eligible Conditions
  • Acid Reflux
  • Peptic Ulcer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood samples were collected predose, once between 0.5 and 2 hours, and once between 2.5 and 4 hours post-dose on days 7 and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples were collected predose, once between 0.5 and 2 hours, and once between 2.5 and 4 hours post-dose on days 7 and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apparent Oral Clearance (CL) of Vonoprazan
Area Under the Plasma Concentration-time Curve During the Dosing Interval τ (AUCτ) of Vonoprazan
Central Volume of Distribution (Vc) of Vonoprazan
+1 more
Secondary study objectives
Number of Participants Experiencing Adverse Events (AEs)

Side effects data

From 2017 Phase 4 trial • 3 Patients • NCT03116841
33%
Viral upper respiratory tract
33%
Gastrointestinal disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vonoprazan 20mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Vonoprazan 20 mgExperimental Treatment1 Intervention
Participants will receive vonoprazan 20 mg once daily for 14 days.
Group II: Vonoprazan 10 mgExperimental Treatment1 Intervention
Participants will receive vonoprazan 10 mg once daily for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vonoprazan
2019
Completed Phase 4
~12720

Find a Location

Who is running the clinical trial?

Phathom Pharmaceuticals, Inc.Lead Sponsor
11 Previous Clinical Trials
4,163 Total Patients Enrolled
Medical DirectorStudy DirectorPhathom Pharmaceuticals
2,900 Previous Clinical Trials
8,090,410 Total Patients Enrolled
~7 spots leftby Dec 2025
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