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Proton Pump Inhibitor

Treatment Sequence 3 for Healthy Subjects

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 4 trial • 3 Patients • NCT03116841

33%

Viral upper respiratory tract

33%

Gastrointestinal disorder

100%

80%

60%

40%

20%

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

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