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Vonoprazan ODT-1 or ODT-2 without Water

Phase 1

Healthy Volunteers | Small molecule | Other |Phathom Pharmaceuticals, Inc.|Last Updated: Dec 19, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06831344A 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 ParticipantsPHASE1 COMPLETED 25 — — Feb 14, 2025Apr 10, 2025Dec 19, 20251 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Drug Concentration (Cmax) of Vonoprazan
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

Cmax of Vonoprazan was reported.

Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan
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

AUC0-t of Vonoprazan was reported.

AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan
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

AUC0-inf of Vonoprazan was reported.

Secondary Endpoints
Time to Maximum Observed Plasma Concentration (Tmax) of Vonoprazan
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
Time Until First Measurable Concentration in Plasma (Tlag) of Vonoprazan
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
Terminal Elimination Rate Constant (λz) of Vonoprazan
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Sequence A, B, C, D, E: Vonoprazan 10 mgEXPERIMENTALParticipants will be randomly assigned to 1 of 5 treatment sequences in a 1:1:1:1:1 ratio. On the first day of each dosing period, participants will receive 1 of the following study treatments according to the treatment sequence they are randomly assigned to: * Treatment A: Vonoprazan 10 mg ODT-1 without water * Treatment B: Vonoprazan 10 mg ODT-1 mixed with water and administered via a syringe * Treatment C: Vonoprazan 10 mg ODT-2 without water * Treatment D: Vonoprazan 10 mg ODT-2 mixed with water and administered via a syringe * Treatment E (reference): Vonoprazan 10 mg tablet. There will be a washout interval of a minimum of 5 days between study drug dosing in each period.
Sequence B, D, E, C, A: Vonoprazan 10 mgEXPERIMENTALParticipants will be randomly assigned to 1 of 5 treatment sequences in a 1:1:1:1:1 ratio. On the first day of each dosing period, participants will receive 1 of the following study treatments according to the treatment sequence they are randomly assigned to: * Treatment A: Vonoprazan 10 mg ODT-1 without water * Treatment B: Vonoprazan 10 mg ODT-1 mixed with water and administered via a syringe * Treatment C: Vonoprazan 10 mg ODT-2 without water * Treatment D: Vonoprazan 10 mg ODT-2 mixed with water and administered via a syringe * Treatment E (reference): Vonoprazan 10 mg tablet. There will be a washout interval of a minimum of 5 days between study drug dosing in each period.
Sequence C, E, B, A, D: Vonoprazan 10 mgEXPERIMENTALParticipants will be randomly assigned to 1 of 5 treatment sequences in a 1:1:1:1:1 ratio. On the first day of each dosing period, participants will receive 1 of the following study treatments according to the treatment sequence they are randomly assigned to: * Treatment A: Vonoprazan 10 mg ODT-1 without water * Treatment B: Vonoprazan 10 mg ODT-1 mixed with water and administered via a syringe * Treatment C: Vonoprazan 10 mg ODT-2 without water * Treatment D: Vonoprazan 10 mg ODT-2 mixed with water and administered via a syringe * Treatment E (reference): Vonoprazan 10 mg tablet. There will be a washout interval of a minimum of 5 days between study drug dosing in each period.
Sequence D, C, A, E, B: Vonoprazan 10 mgEXPERIMENTALParticipants will be randomly assigned to 1 of 5 treatment sequences in a 1:1:1:1:1 ratio. On the first day of each dosing period, participants will receive 1 of the following study treatments according to the treatment sequence they are randomly assigned to: * Treatment A: Vonoprazan 10 mg ODT-1 without water * Treatment B: Vonoprazan 10 mg ODT-1 mixed with water and administered via a syringe * Treatment C: Vonoprazan 10 mg ODT-2 without water * Treatment D: Vonoprazan 10 mg ODT-2 mixed with water and administered via a syringe * Treatment E (reference): Vonoprazan 10 mg tablet. There will be a washout interval of a minimum of 5 days between study drug dosing in each period.
Sequence E, A, D, B, C: Vonoprazan 10 mgEXPERIMENTALParticipants will be randomly assigned to 1 of 5 treatment sequences in a 1:1:1:1:1 ratio. On the first day of each dosing period, participants will receive 1 of the following study treatments according to the treatment sequence they are randomly assigned to: * Treatment A: Vonoprazan 10 mg ODT-1 without water * Treatment B: Vonoprazan 10 mg ODT-1 mixed with water and administered via a syringe * Treatment C: Vonoprazan 10 mg ODT-2 without water * Treatment D: Vonoprazan 10 mg ODT-2 mixed with water and administered via a syringe * Treatment E (reference): Vonoprazan 10 mg tablet. There will be a washout interval of a minimum of 5 days between study drug dosing in each period.
Interventions
NameTypeDescription
Vonoprazan ODT-1 or ODT-2 without WaterDRUGVonoprazan will be administered orally as an ODT-1 or ODT-2 without water
Vonoprazan ODT-1 or ODT-2 with WaterDRUGVonoprazan will be administered orally as an ODT-1 or ODT-2 with water via a syringe
Vonoprazan (Reference)DRUGVonoprazan will be administered orally as a tablet
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The participant is 18 to 55 years of age, inclusive, at Screening. * The participant has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at Screening. * The participant is considered by the investigator to be in good general health as determined by medical history, clinical...

Countries:United States
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