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Proton Pump Inhibitor
A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to take vonoprazan, a medicine that reduces stomach acid, by sprinkling it on food like pudding or applesauce. The study involves healthy participants to see how well the body absorbs the medicine in this new form compared to the traditional tablet. Vonoprazan helps treat conditions like heartburn by blocking acid production in the stomach.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2017 Phase 4 trial • 3 Patients • NCT0311684133%
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
3Treatment groups
Experimental Treatment
Group I: Treatment Sequence 3Experimental Treatment1 Intervention
Participants assigned to Treatment Sequence 3 will receive vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 1, vonoprazan 20 mg as a tablet on Day 1 of Treatment Period 2, and vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 3.
Group II: Treatment Sequence 2Experimental Treatment1 Intervention
Participants assigned to Treatment Sequence 2 will receive vonoprazan 20 mg as a tablet on Day 1 of Treatment Period 1, vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 2, and vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 3.
Group III: Treatment Sequence 1Experimental Treatment1 Intervention
Participants assigned to Treatment Sequence 1 will receive vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 1, vonoprazan 20 mg as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 2, and vonoprazan 20 mg as a tablet on Day 1 of Treatment Period 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vonoprazan
2019
Completed Phase 4
~12720
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Phathom Pharmaceuticals, Inc.Lead Sponsor
11 Previous Clinical Trials
4,160 Total Patients Enrolled
Medical DirectorStudy DirectorPhathom Pharmaceuticals
2,905 Previous Clinical Trials
8,091,442 Total Patients Enrolled