Trial Outcomes & Findings for A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants (NCT NCT05366738)
NCT ID: NCT05366738
Last Updated: 2024-03-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Day 1 of each 3-day Treatment Period: Within 0.25 hours 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
2024-03-29
Participant Flow
27 participants were randomized in a 1:1:1 ratio to 1 of 3 treatment sequences at 1 site in the United States.
Screening assessments were conducted within 28 days before randomization.
Participant milestones
| Measure |
Vonoprazan 20 mg: Treatment Sequence 1
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 1, orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 2, and orally as a tablet on Day 1 of Treatment Period 3. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. There was a washout interval of a minimum of 7 days between study drug dosing in each period.
|
Vonoprazan 20 mg: Treatment Sequence 2
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of Treatment Period 1, orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 2, and orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 3. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. There was a washout interval of a minimum of 7 days between study drug dosing in each period.
|
Vonoprazan 20 mg: Treatment Sequence 3
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 1, orally as a tablet on Day 1 of Treatment Period 2, and orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 3. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. There was a washout interval of a minimum of 7 days between study drug dosing in each period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
|
Overall Study
Completed Treatment A (Vonoprazan 20 mg Sprinkle Capsule on Pudding)
|
9
|
8
|
9
|
|
Overall Study
Completed Treatment B (Vonoprazan 20 mg Sprinkle Capsule on Applesauce)
|
9
|
8
|
9
|
|
Overall Study
Completed Treatment C (Vonoprazan 20 mg Tablet)
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Vonoprazan 20 mg: Treatment Sequence 1
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 1, orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 2, and orally as a tablet on Day 1 of Treatment Period 3. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. There was a washout interval of a minimum of 7 days between study drug dosing in each period.
|
Vonoprazan 20 mg: Treatment Sequence 2
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of Treatment Period 1, orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 2, and orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 3. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. There was a washout interval of a minimum of 7 days between study drug dosing in each period.
|
Vonoprazan 20 mg: Treatment Sequence 3
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 1, orally as a tablet on Day 1 of Treatment Period 2, and orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 3. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. There was a washout interval of a minimum of 7 days between study drug dosing in each period.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants
Baseline characteristics by cohort
| Measure |
Vonoprazan 20 mg: Treatment Sequence 1
n=9 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 1, orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 2, and orally as a tablet on Day 1 of Treatment Period 3. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. There was a washout interval of a minimum of 7 days between study drug dosing in each period.
|
Vonoprazan 20 mg: Treatment Sequence 2
n=9 Participants
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of Treatment Period 1, orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 2, and orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 3. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. There was a washout interval of a minimum of 7 days between study drug dosing in each period.
|
Vonoprazan 20 mg: Treatment Sequence 3
n=9 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of Treatment Period 1, orally as a tablet on Day 1 of Treatment Period 2, and orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of Treatment Period 3. Each treatment period was 3 days, with treatment received on Day 1 of each treatment period. There was a washout interval of a minimum of 7 days between study drug dosing in each period.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 7.22 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 8.51 • n=7 Participants
|
35.8 years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 8.27 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.Population: Measured in the pharmacokinetic (PK) population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified.
Outcome measures
| Measure |
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment C: Vonoprazan 20 mg Tablet
n=27 Participants
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan
|
228 ng•h/mL
Geometric Coefficient of Variation 44.9
|
216 ng•h/mL
Geometric Coefficient of Variation 46.0
|
219 ng•h/mL
Geometric Coefficient of Variation 47.3
|
PRIMARY outcome
Timeframe: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.Population: Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified.
Outcome measures
| Measure |
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment C: Vonoprazan 20 mg Tablet
n=27 Participants
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan
|
238 ng•h/mL
Geometric Coefficient of Variation 43.2
|
227 ng•h/mL
Geometric Coefficient of Variation 43.1
|
231 ng•h/mL
Geometric Coefficient of Variation 44.4
|
PRIMARY outcome
Timeframe: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.Population: Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified.
Outcome measures
| Measure |
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment C: Vonoprazan 20 mg Tablet
n=27 Participants
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Vonoprazan
|
23.1 ng/mL
Geometric Coefficient of Variation 44.2
|
22.4 ng/mL
Geometric Coefficient of Variation 41.9
|
22.3 ng/mL
Geometric Coefficient of Variation 45.3
|
SECONDARY outcome
Timeframe: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.Population: Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified.
Outcome measures
| Measure |
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment C: Vonoprazan 20 mg Tablet
n=27 Participants
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Vonoprazan
|
2.00 hours
Interval 1.5 to 6.0
|
2.01 hours
Interval 1.0 to 6.0
|
2.00 hours
Interval 1.5 to 6.02
|
SECONDARY outcome
Timeframe: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.Population: Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified.
Outcome measures
| Measure |
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment C: Vonoprazan 20 mg Tablet
n=27 Participants
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
|---|---|---|---|
|
Terminal Phase Half-life (t1/2) of Vonoprazan
|
7.50 hours
Geometric Coefficient of Variation 19.5
|
7.20 hours
Geometric Coefficient of Variation 18.4
|
7.29 hours
Geometric Coefficient of Variation 16.0
|
SECONDARY outcome
Timeframe: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.Population: Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified.
Outcome measures
| Measure |
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment C: Vonoprazan 20 mg Tablet
n=27 Participants
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of Vonoprazan
|
83.9 litres/h
Geometric Coefficient of Variation 43.2
|
88.1 litres/h
Geometric Coefficient of Variation 43.1
|
86.6 litres/h
Geometric Coefficient of Variation 44.4
|
SECONDARY outcome
Timeframe: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.Population: Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified.
Outcome measures
| Measure |
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment C: Vonoprazan 20 mg Tablet
n=27 Participants
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Vonoprazan
|
908 litres
Geometric Coefficient of Variation 37.6
|
915 litres
Geometric Coefficient of Variation 33.4
|
911 litres
Geometric Coefficient of Variation 38.5
|
SECONDARY outcome
Timeframe: Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose.Population: Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified.
Outcome measures
| Measure |
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce
n=26 Participants
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment C: Vonoprazan 20 mg Tablet
n=27 Participants
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) of Vonoprazan
|
0.0924 1/h
Geometric Coefficient of Variation 19.5
|
0.0963 1/h
Geometric Coefficient of Variation 18.4
|
0.0951 1/h
Geometric Coefficient of Variation 16.0
|
Adverse Events
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment C: Vonoprazan 20 mg Tablet
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding
n=26 participants at risk
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce
n=26 participants at risk
Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
Treatment C: Vonoprazan 20 mg Tablet
n=27 participants at risk
Participants received vonoprazan 20 mg orally as a tablet on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/26 • Day 1 to Day 31
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.
|
7.7%
2/26 • Day 1 to Day 31
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%
0/27 • Day 1 to Day 31
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
Muscle contractions involuntary
|
0.00%
0/26 • Day 1 to Day 31
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%
0/26 • Day 1 to Day 31
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.
|
3.7%
1/27 • Day 1 to Day 31
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
Abdominal discomfort
|
0.00%
0/26 • Day 1 to Day 31
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%
0/26 • Day 1 to Day 31
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.
|
3.7%
1/27 • Day 1 to Day 31
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
Oral mucosal roughening
|
0.00%
0/26 • Day 1 to Day 31
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%
0/26 • Day 1 to Day 31
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.
|
3.7%
1/27 • Day 1 to Day 31
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.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.8%
1/26 • Day 1 to Day 31
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%
0/26 • Day 1 to Day 31
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%
0/27 • Day 1 to Day 31
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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
3.8%
1/26 • Day 1 to Day 31
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%
0/26 • Day 1 to Day 31
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%
0/27 • Day 1 to Day 31
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.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/26 • Day 1 to Day 31
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%
0/26 • Day 1 to Day 31
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.
|
3.7%
1/27 • Day 1 to Day 31
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