NCT06831344

A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants

A Phase 1, Open-Label, Randomized, Single-Dose, 5-Period Crossover Study to Determine the Bioavailability of Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Phathom Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Vonoprazan ODT-1 or ODT-2 without Water	Vonoprazan will be administered orally as an ODT-1 or ODT-2 without water
DRUG	Vonoprazan ODT-1 or ODT-2 with Water	Vonoprazan will be administered orally as an ODT-1 or ODT-2 with water via a syringe
DRUG	Vonoprazan (Reference)	Vonoprazan will be administered orally as a tablet

Timeline

• Start date: 2025-02-14
• Primary completion: 2025-04-05
• Completion: 2025-04-10
• First posted: 2025-02-18
• Last updated: 2025-12-19
• Results posted: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study