Trial Outcomes & Findings for 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 (NCT NCT06831344)
NCT ID: NCT06831344
Last Updated: 2025-12-19
Results Overview
Cmax of Vonoprazan was reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
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
Results posted on
2025-12-19
Participant Flow
This study was conducted at single center in the United States from 14 February 2025 to 10 April 2025.
A total of 25 healthy participants were enrolled in this 5-period crossover study and were randomized to 1 of 5 treatment sequences to receive vonoprazan as two formulations (orally dispersible tablet \[ODT\]-1 and ODT-2) with or without water. The reference formulation was vonoprazan 10 milligram (mg) tablets (Treatment E).
Participant milestones
| Measure |
Vonoprazan 10 mg: Treatment Sequence 1
Participants received Vonoprazan 10 mg, orally, in the following sequence: ODT-1, once on Day 1 of Period 1 without water as Treatment A, ODT-1, once on Day 1 of Period 2 mixed with water and administered via a syringe as Treatment B, ODT-2, once on Day 1 of Period 3 without water as Treatment C, ODT-2, once on Day 1 of Period 4 mixed with water and administered via a syringe as Treatment D, and Vonoprazan 10 mg tablet, once on Day 1 of Period 5 as Treatment E. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. A washout interval of minimum of 5 days was maintained between doses in each treatment period.
|
Vonoprazan 10 mg: Treatment Sequence 2
Participants received Vonoprazan 10 mg, orally, in the following sequence: ODT-1, once on Day 1 of Period 1 mixed with water and administered via a syringe as Treatment B, ODT-2, once on Day 1 of Period 2 mixed with water and administered via a syringe as Treatment D, Vonoprazan 10 mg tablet, once on Day 1 of Period 3 as Treatment E, ODT-2, once on Day 1 of Period 4 without water as Treatment C, ODT-1, and once on Day 1 of Period 5 without water as Treatment A. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. A washout interval of minimum of 5 days was maintained between doses in each treatment period.
|
Vonoprazan 10 mg: Treatment Sequence 3
Participants received Vonoprazan 10 mg, orally, in the following sequence: ODT-2, once on Day 1 of Period 1 without water as Treatment C, Vonoprazan 10 mg tablet, once on Day 1 of Period 2 as Treatment E, ODT-1, once on Day 1 of Period 3 mixed with water and administered via a syringe as Treatment B, ODT-1, once on Day 1 of Period 4 without water as Treatment A and ODT-2, once on Day 1 of Period 5 mixed with water and administered via a syringe as Treatment D. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. A washout interval of minimum of 5 days was maintained between doses in each treatment period.
|
Vonoprazan 10 mg: Treatment Sequence 4
Participants received Vonoprazan 10 mg, orally, in the following sequence: ODT-2, once on Day 1 of Period 1 mixed with water and administered via a syringe as Treatment D, ODT-2, once on Day 1 of Period 2 without water as Treatment C, ODT-1, once on Day 1 of Period 3 without water as Treatment A, Vonoprazan 10 mg tablet, once on Day 1 of Period 4 as Treatment E and ODT-1, once on Day 1 of Period 5 mixed with water and administered via a syringe as Treatment B. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. A washout interval of minimum of 5 days was maintained between doses in each treatment period.
|
Vonoprazan 10 mg: Treatment Sequence 5
Participants received Vonoprazan 10 mg, orally, in the following sequence: Vonoprazan 10 mg tablet, once on Day 1 of Period 1 as Treatment E, ODT-1, once on Day 1 of Period 2 without water as Treatment A, ODT-2, once on Day 1 of Period 3 mixed with water and administered via a syringe as Treatment D, ODT-1, once on Day 1 of Period 4 mixed with water and administered via a syringe as Treatment B and ODT-2, once on Day 1 of Period 5 without water as Treatment C. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. A washout interval of minimum of 5 days was maintained between doses in each treatment period.
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|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
All participants who were randomized to receive Vonoprazan 10 mg, orally, in one of the five treatment sequence: ODT-1, once on Day 1 of Period 1 without water as Treatment A, ODT-1, once on Day 1 of Period 2 mixed with water and administered via a syringe as Treatment B, ODT-2, once on Day 1 of Period 3 without water as Treatment C, ODT-2, once on Day 1 of Period 4 mixed with water and administered via a syringe as Treatment D, and Vonoprazan 10 mg tablet, once on Day 1 of Period 5 as Treatment E. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. A washout interval of minimum of 5 days was maintained between each treatment period.
|
|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 8.66 • n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The Pharmacokinetic (PK) population included participants who received at least 1 dose of study drug and had sufficient concentration data to support accurate estimation of at least 1 PK parameter.
Cmax of Vonoprazan was reported.
Outcome measures
| Measure |
Treatment A: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment B: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment C: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment D: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment E: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg tablets, orally, once on Day 1 of the allocated period.
|
|---|---|---|---|---|---|
|
Maximum Observed Drug Concentration (Cmax) of Vonoprazan
|
6.11 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.8
|
5.81 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 41.4
|
5.46 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36.1
|
5.72 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 46.2
|
5.40 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38.4
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK population included participants who received at least 1 dose of study drug and had sufficient concentration data to support accurate estimation of at least 1 PK parameter.
AUC0-t of Vonoprazan was reported.
Outcome measures
| Measure |
Treatment A: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment B: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment C: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment D: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment E: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg tablets, orally, once on Day 1 of the allocated period.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan
|
57.1 ng*hour/mL
Geometric Coefficient of Variation 45.8
|
54.8 ng*hour/mL
Geometric Coefficient of Variation 42.0
|
52.8 ng*hour/mL
Geometric Coefficient of Variation 41.7
|
51.7 ng*hour/mL
Geometric Coefficient of Variation 47.6
|
49.8 ng*hour/mL
Geometric Coefficient of Variation 38.5
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK population included participants who received at least 1 dose of study drug and had sufficient concentration data to support accurate estimation of at least 1 PK parameter.
AUC0-inf of Vonoprazan was reported.
Outcome measures
| Measure |
Treatment A: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment B: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment C: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment D: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment E: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg tablets, orally, once on Day 1 of the allocated period.
|
|---|---|---|---|---|---|
|
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan
|
59.2 ng*hour/mL
Geometric Coefficient of Variation 44.3
|
57.1 ng*hour/mL
Geometric Coefficient of Variation 39.4
|
55.3 ng*hour/mL
Geometric Coefficient of Variation 39.0
|
54.1 ng*hour/mL
Geometric Coefficient of Variation 44.9
|
51.9 ng*hour/mL
Geometric Coefficient of Variation 36.3
|
SECONDARY outcome
Timeframe: 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-dosePopulation: The PK population included participants who received at least 1 dose of study drug and had sufficient concentration data to support accurate estimation of at least 1 PK parameter.
Tmax of Vonoprazan was reported.
Outcome measures
| Measure |
Treatment A: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment B: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment C: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment D: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment E: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg tablets, orally, once on Day 1 of the allocated period.
|
|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Vonoprazan
|
2.00 hours
Interval 1.5 to 6.0
|
2.00 hours
Interval 1.5 to 6.0
|
2.12 hours
Interval 1.5 to 4.08
|
2.00 hours
Interval 1.5 to 6.0
|
2.00 hours
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 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-dosePopulation: The PK population included participants who received at least 1 dose of study drug and had sufficient concentration data to support accurate estimation of at least 1 PK parameter.
Tlag of Vonoprazan was reported.
Outcome measures
| Measure |
Treatment A: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment B: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment C: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment D: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment E: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg tablets, orally, once on Day 1 of the allocated period.
|
|---|---|---|---|---|---|
|
Time Until First Measurable Concentration in Plasma (Tlag) of Vonoprazan
|
0.32 hours
Interval 0.25 to 1.02
|
0.25 hours
Interval 0.25 to 1.0
|
0.32 hours
Interval 0.25 to 1.0
|
0.25 hours
Interval 0.25 to 1.5
|
0.27 hours
Interval 0.25 to 1.5
|
SECONDARY outcome
Timeframe: 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-dosePopulation: The PK population included participants who received at least 1 dose of study drug and had sufficient concentration data to support accurate estimation of at least 1 PK parameter.
λz of Vonoprazan was reported.
Outcome measures
| Measure |
Treatment A: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment B: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment C: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment D: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment E: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg tablets, orally, once on Day 1 of the allocated period.
|
|---|---|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) of Vonoprazan
|
0.0948 per hour
Standard Deviation 0.0175
|
0.0998 per hour
Standard Deviation 0.0188
|
0.0955 per hour
Standard Deviation 0.0167
|
0.0963 per hour
Standard Deviation 0.0140
|
0.0975 per hour
Standard Deviation 0.0185
|
SECONDARY outcome
Timeframe: 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-dosePopulation: The PK population included participants who received at least 1 dose of study drug and had sufficient concentration data to support accurate estimation of at least 1 PK parameter.
t1/2 of Vonoprazan was reported.
Outcome measures
| Measure |
Treatment A: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment B: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment C: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment D: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment E: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg tablets, orally, once on Day 1 of the allocated period.
|
|---|---|---|---|---|---|
|
Terminal Phase Half-life (t1/2) of Vonoprazan
|
7.54 hours
Standard Deviation 1.36
|
7.20 hours
Standard Deviation 1.42
|
7.48 hours
Standard Deviation 1.38
|
7.36 hours
Standard Deviation 1.22
|
7.35 hours
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: 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-dosePopulation: The PK population included participants who received at least 1 dose of study drug and had sufficient concentration data to support accurate estimation of at least 1 PK parameter.
CL/F of Vonoprazan was reported.
Outcome measures
| Measure |
Treatment A: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment B: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment C: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment D: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment E: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg tablets, orally, once on Day 1 of the allocated period.
|
|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of Vonoprazan
|
184 litres/hour (L/h)
Standard Deviation 78.9
|
188 litres/hour (L/h)
Standard Deviation 76.0
|
193 litres/hour (L/h)
Standard Deviation 72.5
|
202 litres/hour (L/h)
Standard Deviation 89.2
|
205 litres/hour (L/h)
Standard Deviation 75.9
|
SECONDARY outcome
Timeframe: 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-dosePopulation: The PK population included participants who received at least 1 dose of study drug and had sufficient concentration data to support accurate estimation of at least 1 PK parameter.
Vz/F of Vonoprazan was reported.
Outcome measures
| Measure |
Treatment A: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment B: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment C: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment D: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg ODT-2 tablets, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment E: Vonoprazan 10 mg
n=25 Participants
Participants received Vonoprazan 10 mg tablets, orally, once on Day 1 of the allocated period.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Vonoprazan
|
1930 litres (L)
Standard Deviation 735
|
1880 litres (L)
Standard Deviation 622
|
2030 litres (L)
Standard Deviation 678
|
2070 litres (L)
Standard Deviation 762
|
2100 litres (L)
Standard Deviation 668
|
Adverse Events
Treatment A: Vonoprazan 10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B: Vonoprazan 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment C: Vonoprazan 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment D: Vonoprazan 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment E: Vonoprazan 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Vonoprazan 10 mg
n=25 participants at risk
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment B: Vonoprazan 10 mg
n=25 participants at risk
Participants received Vonoprazan 10 mg ODT-1 tablets, orally, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment C: Vonoprazan 10 mg
n=25 participants at risk
Participants received Vonoprazan 10 mg ODT-2 tablets, orally, once on Day 1 of the allocated period without water.
|
Treatment D: Vonoprazan 10 mg
n=25 participants at risk
Participants received Vonoprazan 10 mg ODT-2 tablets, once on Day 1 of the allocated period mixed with water and administered via a syringe.
|
Treatment E: Vonoprazan 10 mg
n=25 participants at risk
Participants received Vonoprazan 10 mg tablets, orally, once on Day 1 of the allocated period.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
4.0%
1/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
4.0%
1/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
4.0%
1/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
4.0%
1/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
4.0%
1/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
0.00%
0/25 • Day 1 to Day 28
All-cause mortality, serious and non-serious adverse events were measured in the safety population, which included all participants who received at least 1 dose of study drug. Safety data are presented for each treatment received, as pre-specified.
|
Additional Information
Phathom Medical Information
Phathom Pharmaceuticals, Inc.
Phone: 1-888-775-7428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigators (PIs) are not permitted to publish the data. Data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the PIs to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority over all such issues.
- Publication restrictions are in place
Restriction type: OTHER