Vonoprazan Formulations in Healthy Participants
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of two vonoprazan orally disintegrating tablet formulations (ODT-1 or ODT-2) administered without water or mixed with water and administered via a syringe relative to the vonoprazan tablet in healthy participants.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any prescription and over-the-counter medications (except hormonal birth control and acetaminophen up to 2 g per day) at least 14 days before the first dose of the study drug and throughout the study.
Is vonoprazan generally safe for humans?
How is the drug vonoprazan different from other treatments for acid-related conditions?
Vonoprazan is unique because it is a potassium-competitive acid blocker, which works differently from traditional proton pump inhibitors (PPIs) by blocking acid production in the stomach more effectively and quickly. This novel mechanism may offer better healing for conditions like erosive esophagitis and ulcers compared to existing treatments.24567
What data supports the effectiveness of the drug vonoprazan?
Research shows that vonoprazan is effective in treating acid-related conditions, such as non-erosive reflux disease and preventing ulcers caused by NSAID use. It has been found to be as effective as lansoprazole, another acid-reducing drug, in healing erosive esophagitis and treating gastric or duodenal ulcers.24578
Who Is on the Research Team?
Medical Director
Principal Investigator
Phathom Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for healthy individuals who can take a single dose of the study drug. Specific eligibility criteria are not provided, but typically participants must be adults without any significant medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of vonoprazan in different formulations across 5 periods with a minimum 5-day washout interval between doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vonoprazan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phathom Pharmaceuticals, Inc.
Lead Sponsor