Vonoprazan for Gastroesophageal Reflux

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Research Center - Elligo, Anaheim, CA
Gastroesophageal Reflux+1 More
Vonoprazan - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions

  • Gastroesophageal Reflux

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gastroesophageal Reflux

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: Day 7: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose.

Day 7
Apparent Oral Clearance (CL/F) of Vonoprazan
Apparent Volume of Distribution (Vz/F) of Vonoprazan
Area Under the Plasma Concentration-time Curve During the Dosing Interval τ (AUCτ) of Vonoprazan
Maximum Observed Drug Concentration at Steady State (Cmax-ss) of Vonoprazan
Terminal Elimination Half-life (t1/2z) of Vonoprazan
Time at Steady State to Reach Cmax,ss (Tmax,ss) of Vonoprazan

Trial Safety

Safety Progress

1 of 3

Other trials for Gastroesophageal Reflux

Side Effects for

Vonoprazan 20mg
33%Gastrointestinal disorder
33%Viral upper respiratory tract
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT03116841) in the Vonoprazan 20mg ARM group. Side effects include: Gastrointestinal disorder with 33%, Viral upper respiratory tract with 33%.

Trial Design

2 Treatment Groups

Vonoprazan 20 mg
1 of 2
Vonoprazan 10 mg
1 of 2
Experimental Treatment

18 Total Participants · 2 Treatment Groups

Primary Treatment: Vonoprazan · No Placebo Group · Phase 1

Vonoprazan 20 mg
Drug
Experimental Group · 1 Intervention: Vonoprazan · Intervention Types: Drug
Vonoprazan 10 mg
Drug
Experimental Group · 1 Intervention: Vonoprazan · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vonoprazan
2019
Completed Phase 4
~12250

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 7: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose.
Closest Location: Advanced Research Center - Elligo · Anaheim, CA
Photo of california 1Photo of california 2Photo of california 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Gastroesophageal Reflux
0 CompletedClinical Trials

Who is running the clinical trial?

Phathom Pharmaceuticals, Inc.Lead Sponsor
8 Previous Clinical Trials
3,372 Total Patients Enrolled
3 Trials studying Gastroesophageal Reflux
1,235 Patients Enrolled for Gastroesophageal Reflux
Medical DirectorStudy DirectorPhathom Pharmaceuticals
2,597 Previous Clinical Trials
8,931,116 Total Patients Enrolled
13 Trials studying Gastroesophageal Reflux
5,321 Patients Enrolled for Gastroesophageal Reflux

Eligibility Criteria

Age < 18 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The participant has a medical history of 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).
Parent or legal guardian (ie, legally authorized representative [LAR]) is willing and able to complete the informed consent process and comply with study procedures and visit schedule
You are a female participant of childbearing potential who is or may be sexually active with a nonsterilized male partner

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.