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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 day 1 of each 3-day treatment period: within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
Awards & highlights

Study Summary

The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of vonoprazan 20 mg sprinkle capsule, either sprinkled on pudding or on applesauce, relative to a vonoprazan 20 mg tablet in healthy participants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of each 3-day treatment period: within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of each 3-day treatment period: within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan
Maximum Observed Plasma Concentration (Cmax) of Vonoprazan
Secondary outcome measures
Apparent Total Body Clearance (CL/F) of Vonoprazan
Apparent Volume of Distribution (Vz/F) of Vonoprazan
Terminal Elimination Rate Constant (λz) of Vonoprazan
+2 more

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

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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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Phathom Pharmaceuticals, Inc.Lead Sponsor
9 Previous Clinical Trials
3,413 Total Patients Enrolled
Medical DirectorStudy DirectorPhathom Pharmaceuticals
2,777 Previous Clinical Trials
8,063,459 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants
2022. "A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05366738.
~9 spots leftby Apr 2025
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