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
← catalyst calendarSponsored by Phathom Pharmaceuticals, Inc. (industry) · PHAT — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Basic science
Enrollment
25actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-02-14 | actual | When the study began enrolling |
| Primary completion | 2025-04-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-10 | actual | The whole study's end, after follow-up |
| First posted | 2025-02-18 | actual | When this record first appeared on the registry |
| Results posted | 2025-12-19 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-12-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteers
Interventions
- Drug: Vonoprazan ODT-1 or ODT-2 without Water
- Drug: Vonoprazan ODT-1 or ODT-2 with Water
- Drug: Vonoprazan (Reference)
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Drug Concentration (Cmax) of Vonoprazan
measured Day 1 of each 3-day treatment period: Within 15 minutes pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan
measured Day 1 of each 3-day treatment period: Within 15 minutes pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan
measured Day 1 of each 3-day treatment period: Within 15 minutes pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-12-10 · 765 KB · Prot_000.pdf
Statistical Analysis Planposted 2025-03-12 · 834 KB · SAP_001.pdf
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