Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to investigate the acid-inhibitory effect of multiple oral doses of Vonoprazan (TAK-438) and the relative effect of vonoprazan versus two controls (esomeprazole and rabeprazole sodium) in healthy Japanese adult male participants with the CYP2C19 extensive metabolizer (EM) genotype.
Detailed description
This is a Phase 3 open-label crossover study to evaluate the acid-inhibitory effect following 7 days multiple doses of vonoprazan (20 mg per dose) and esomeprazole (20 mg per dose) (Cohort 1) or vonoprazan (20 mg per dose) and rabeprazole sodium (10 mg per dose) (Cohort 2) in healthy Japanese adult male participants (CYP2C19 genotype: EM). There will be a total of 20 participants, 5 per group for both Cohorts 1 and 2. At least 2 participants each with the homo EM (\*1/\*1) or hetero EM (\*1/\*2, \*1/\*3) CYP2C19 genotype will be enrolled among the 5 participants per group. The drug being tested in this study is called vonoprazan. This study will look at the acid inhibitory effect following 7 days multiple doses of vonoprazan and esomeprazole (Cohort 1) or vonoprazan and rabeprazole sodium (Cohort 2) in healthy Japanese adult male participants with the CYP2C19 EM genotype. The study will enroll a total of 20 participants, 5 per group for both Cohorts. At least 2 participants each with the homo EM (\*1/\*1) or hetero EM (\*1/\*2, \*1/\*3) CYP2C19 genotype will be enrolled among the 5 participants per group. * Group A, Cohort 1: vonoprazan (20 mg per dose for 7 days) followed by esomeprazole (20 mg per dose for 7 days) * Group B, Cohort 1: esomeprazole (20 mg per dose for 7 days) followed by TAK-438 (20 mg per dose for 7 days) * Group C, Cohort 2: vonoprazan (20 mg per dose for 7 days) followed by rabeprazole sodium (10 mg per dose for 7 days) * Group D, Cohort 2: rabeprazole sodium (10 mg per dose for 7 days) followed by vonoprazan (20 mg per dose for 7 days). All participants will be asked to take Study Medication at the same time each day throughout the study. This single center trial will be conducted in Japan. The overall time to participate in this study is 31 days.
Interventions
DRUGVonoprazan
Vonoprazan tablets
DRUGEsomeprazole
Esomeprazole capsules
DRUGRabeprazole sodium
Rabeprazole sodium tablets
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is a healthy Japanese adult male volunteer. 2. Is aged 20 to 45 years, inclusive, at the time of informed consent. 3. Has been confirmed at CYP2C19 genotyping as an Extensive Metabolizer \[EM (\*1/\*1,\*1/\*2,\*1/\*3)\]. 4. Capable of understanding and complying with the protocol requirements. 5. The participant signs and dates a written informed consent form prior to the initiation of any study procedures. 6. Weighs 50 kg or more and has body mass index (BMI) of 18.5 or more and less than 25.0 kg/m\^2 at Screening or admission (Day -3). 7. H. pylori-negative at Screening.
Exclusion criteria
1. Has undergone resection of the upper gastrointestinal tract or vagotomy. 2. Was determined to have hypoacidity or anacidity. 3. Has a present or past history of acid-related disease (reflux esophagitis, gastric ulcer, duodenal ulcer, non-erosive gastroesophageal reflux, Barrett's esophagus, Zollinger-Ellison syndrome, etc.). 4. Has undergone eradication of H. pylori within 6 months prior to the start of the study drug administration. 5. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormalities which may impact the ability of the subject to participate or potentially confound the study results. 6. Has a known hypersensitivities or allergies to drugs or food. 7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the start of the study drug administration. 8. Has poor peripheral venous access. 9. Had 200 mL or more of whole blood drawn within 4 weeks (28 days) prior to the start of the study drug administration or 400 mL or more of whole blood drawn within 12 weeks (84 days) prior to the start of the study drug administration. 10. Had a total volume of 800 mL or more of whole blood drawn within 52 weeks (364 days) prior to the start of the study drug administration. 11. Has undergone blood component draw within 2 weeks (14 days) prior to the start of the study drug administration. 12. Requires treatment with any of the excluded medications specified in the study or requires nutrition with any vitamin supplements or foods prohibited in the study. 13. Has received study medication within 16 weeks (112 days) prior to the start of the study drug administration. 14. Has received vonoprazan (TAK-438) in the past. 15. Has a history of cancer. 16. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen or serological reaction for syphilis at Screening. 17. Has a Screening or admission (Day -3) abnormal clinically significant electrocardiogram (ECG). 18. Has abnormal Screening or admission (Day -3) laboratory values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> twice the upper limit of the normal range. 19. Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress. 20. Participant who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intragastric pH Time Course Over 24 Hours | At baseline (Day -2 to Day -1), administration period (Days 1 to Day 2 and Days 7 to Day 8) | Intragastric pH was measured continuously for 24 hours (hr) by pH monitor. pH holding time ratio (HTR) is the percentage of time a pH is maintained at a particular level. For example, pH 4 HTR is the percentage of time the pH = 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events | 31 days | The frequency of adverse events by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug. |
| Number of Participants With Abnormal Changes From Baseline in Vital Signs | At screening, baseline (Day -3, Day -2, Day -1), administration period (Days 1, Day 2, Day 7, Day 8), and post-test (Day 28) | Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). |
| Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings | At Screening, baseline (Day -3), administration period (Day 8), and post-test (Day 28) | — |
| Number of Participants With Markedly Abnormal Laboratory Values | At Screening, baseline (Day -3), administration period (Day 1, Day 8), and post-test (Day 28) | The number of participants with markedly abnormal laboratory values for Chemistry, Hematology and Urinalysis during the study is reported. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in Japan from 3 February 2014 to 27 March 2014.
Pre-assignment details
A total of 56 participants signed the informed consent form. 20 participants were enrolled and received the study drug. The primary reason for ineligibility to receive the study drug was did not meet entrance criteria for 16 subjects. Nineteen subjects completed the study, while 1 subject withdrew due to a pretreatment event/AE.
Participants by arm
| Arm | Count |
|---|---|
| Sequence A (Cohort 1): Vonoprazan + Esomeprazole Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days. | 5 |
| Sequence B (Cohort 1): Esomeprazole + Vonoprazan Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days. | 5 |
| Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days. | 5 |
| Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days. | 5 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Treatment Period 1 | Pre-treatment Event/Adverse Event | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Sequence A (Cohort 1): Vonoprazan + Esomeprazole | Total | Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan | Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium | Sequence B (Cohort 1): Esomeprazole + Vonoprazan |
|---|---|---|---|---|---|
| Age, Continuous | 34.0 years STANDARD_DEVIATION 6.93 | 25.2 years STANDARD_DEVIATION 5.31 | 25.2 years STANDARD_DEVIATION 2.95 | 22.2 years STANDARD_DEVIATION 2.95 | 23.8 years STANDARD_DEVIATION 5.17 |
| Body Mass Index (BMI) | 21.56 kg/m^2 STANDARD_DEVIATION 1.674 | 21.05 kg/m^2 STANDARD_DEVIATION 1.387 | 20.34 kg/m^2 STANDARD_DEVIATION 1.222 | 20.96 kg/m^2 STANDARD_DEVIATION 0.808 | 21.32 kg/m^2 STANDARD_DEVIATION 1.844 |
| CPY2C19 Genotype Test (N) Hetero EM | 3 participants | 10 participants | 3 participants | 2 participants | 2 participants |
| CPY2C19 Genotype Test (N) Homo Extensive Metabolizer (EM) | 2 participants | 10 participants | 2 participants | 3 participants | 3 participants |
| CPY2C19 Genotype Test (N) Poor Metabolizer (PM) | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Height | 172.0 cm STANDARD_DEVIATION 7.75 | 171.8 cm STANDARD_DEVIATION 6.48 | 169.4 cm STANDARD_DEVIATION 4.88 | 172.8 cm STANDARD_DEVIATION 6.76 | 173.0 cm STANDARD_DEVIATION 6.52 |
| Region of Enrollment Japan | 5 participants | 20 participants | 5 participants | 5 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 20 Participants | 5 Participants | 5 Participants | 5 Participants |
| Weight | 64.10 kg STANDARD_DEVIATION 8.93 | 62.31 kg STANDARD_DEVIATION 7.245 | 58.34 kg STANDARD_DEVIATION 5.227 | 62.68 kg STANDARD_DEVIATION 5.008 | 64.10 kg STANDARD_DEVIATION 9.813 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 3 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Intragastric pH Time Course Over 24 Hours
Intragastric pH was measured continuously for 24 hours (hr) by pH monitor. pH holding time ratio (HTR) is the percentage of time a pH is maintained at a particular level. For example, pH 4 HTR is the percentage of time the pH = 4.
Time frame: At baseline (Day -2 to Day -1), administration period (Days 1 to Day 2 and Days 7 to Day 8)
Population: Pharmacodynamic (PD) Analysis Set - Participants receiving study medication who completed protocol procedures without serious violation of the protocol were eligible for PD analysis. All 10 subjects from Cohort 1 were included. Three subjects in Cohort 2 were excluded from the PD analysis set, which therefore consisted of 7 subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Baseline | 8.18 percentage of time | Standard Deviation 13.735 |
| Cohort 1 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Day 7 | 96.45 percentage of time | Standard Deviation 4.402 |
| Cohort 1 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Day 7 | 75.21 percentage of time | Standard Deviation 26.398 |
| Cohort 1 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Baseline | 12.98 percentage of time | Standard Deviation 11.139 |
| Cohort 1 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Day 7 | 85.82 percentage of time | Standard Deviation 14.748 |
| Cohort 1 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Day 1 | 71.37 percentage of time | Standard Deviation 17.03 |
| Cohort 1 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Day 1 | 67.86 percentage of time | Standard Deviation 28.345 |
| Cohort 1 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Day 1 | 74.83 percentage of time | Standard Deviation 9.681 |
| Cohort 1 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Baseline | 10.63 percentage of time | Standard Deviation 7.391 |
| Cohort 1 - Esomeprazole 20 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Day 1 | 34.89 percentage of time | Standard Deviation 24.645 |
| Cohort 1 - Esomeprazole 20 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Baseline | 8.18 percentage of time | Standard Deviation 13.735 |
| Cohort 1 - Esomeprazole 20 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Day 7 | 77.62 percentage of time | Standard Deviation 17.302 |
| Cohort 1 - Esomeprazole 20 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Day 1 | 23.92 percentage of time | Standard Deviation 16.896 |
| Cohort 1 - Esomeprazole 20 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Baseline | 10.63 percentage of time | Standard Deviation 7.391 |
| Cohort 1 - Esomeprazole 20 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Day 7 | 61.21 percentage of time | Standard Deviation 17.14 |
| Cohort 1 - Esomeprazole 20 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Day 7 | 44.81 percentage of time | Standard Deviation 17.338 |
| Cohort 1 - Esomeprazole 20 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Day 1 | 12.94 percentage of time | Standard Deviation 10.876 |
| Cohort 1 - Esomeprazole 20 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Baseline | 12.98 percentage of time | Standard Deviation 11.139 |
| Cohort 2 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Day 1 | 84.03 percentage of time | Standard Deviation 7.81 |
| Cohort 2 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Baseline | 8.90 percentage of time | Standard Deviation 6.472 |
| Cohort 2 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Day 1 | 84.16 percentage of time | Standard Deviation 12.383 |
| Cohort 2 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Day 7 | 93.79 percentage of time | Standard Deviation 7.31 |
| Cohort 2 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Baseline | 8.01 percentage of time | Standard Deviation 5.73 |
| Cohort 2 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Day 7 | 98.83 percentage of time | Standard Deviation 2.968 |
| Cohort 2 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Baseline | 9.77 percentage of time | Standard Deviation 14.096 |
| Cohort 2 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Day 1 | 84.34 percentage of time | Standard Deviation 20.254 |
| Cohort 2 - Vonoprazan 20 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Day 7 | 88.77 percentage of time | Standard Deviation 14.369 |
| Cohort 2 - Rabeprazole Sodium 10 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Baseline | 9.77 percentage of time | Standard Deviation 14.096 |
| Cohort 2 - Rabeprazole Sodium 10 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Baseline | 8.01 percentage of time | Standard Deviation 5.73 |
| Cohort 2 - Rabeprazole Sodium 10 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Day 7 | 65.09 percentage of time | Standard Deviation 14.159 |
| Cohort 2 - Rabeprazole Sodium 10 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Day 7 | 54.13 percentage of time | Standard Deviation 25.275 |
| Cohort 2 - Rabeprazole Sodium 10 mg | Intragastric pH Time Course Over 24 Hours | 12-24 hr pH 4 HTR (%)-Day 1 | 15.34 percentage of time | Standard Deviation 13.317 |
| Cohort 2 - Rabeprazole Sodium 10 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Day 1 | 26.29 percentage of time | Standard Deviation 13.381 |
| Cohort 2 - Rabeprazole Sodium 10 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Day 7 | 76.06 percentage of time | Standard Deviation 9.591 |
| Cohort 2 - Rabeprazole Sodium 10 mg | Intragastric pH Time Course Over 24 Hours | 0-12 hr pH 4 HTR (%)-Day 1 | 37.26 percentage of time | Standard Deviation 20.384 |
| Cohort 2 - Rabeprazole Sodium 10 mg | Intragastric pH Time Course Over 24 Hours | 0-24 hr pH 4 HTR (%)-Baseline | 8.90 percentage of time | Standard Deviation 6.472 |
Secondary
Frequency of Adverse Events
The frequency of adverse events by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.
Time frame: 31 days
Population: Safety analysis set - All participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 - Vonoprazan 20 mg | Frequency of Adverse Events | Severe | 0 participants |
| Cohort 1 - Vonoprazan 20 mg | Frequency of Adverse Events | Mild | 0 participants |
| Cohort 1 - Vonoprazan 20 mg | Frequency of Adverse Events | Not Related | 0 participants |
| Cohort 1 - Vonoprazan 20 mg | Frequency of Adverse Events | Leading to Study Drug Discontinuation | 0 participants |
| Cohort 1 - Vonoprazan 20 mg | Frequency of Adverse Events | Moderate | 0 participants |
| Cohort 1 - Vonoprazan 20 mg | Frequency of Adverse Events | Related | 0 participants |
| Cohort 1 - Vonoprazan 20 mg | Frequency of Adverse Events | Treatment Emergent Adverse Events | 0 participants |
| Cohort 1 - Esomeprazole 20 mg | Frequency of Adverse Events | Mild | 0 participants |
| Cohort 1 - Esomeprazole 20 mg | Frequency of Adverse Events | Treatment Emergent Adverse Events | 0 participants |
| Cohort 1 - Esomeprazole 20 mg | Frequency of Adverse Events | Related | 0 participants |
| Cohort 1 - Esomeprazole 20 mg | Frequency of Adverse Events | Not Related | 0 participants |
| Cohort 1 - Esomeprazole 20 mg | Frequency of Adverse Events | Moderate | 0 participants |
| Cohort 1 - Esomeprazole 20 mg | Frequency of Adverse Events | Severe | 0 participants |
| Cohort 1 - Esomeprazole 20 mg | Frequency of Adverse Events | Leading to Study Drug Discontinuation | 0 participants |
| Cohort 2 - Vonoprazan 20 mg | Frequency of Adverse Events | Related | 1 participants |
| Cohort 2 - Vonoprazan 20 mg | Frequency of Adverse Events | Mild | 2 participants |
| Cohort 2 - Vonoprazan 20 mg | Frequency of Adverse Events | Moderate | 1 participants |
| Cohort 2 - Vonoprazan 20 mg | Frequency of Adverse Events | Leading to Study Drug Discontinuation | 1 participants |
| Cohort 2 - Vonoprazan 20 mg | Frequency of Adverse Events | Severe | 0 participants |
| Cohort 2 - Vonoprazan 20 mg | Frequency of Adverse Events | Treatment Emergent Adverse Events | 3 participants |
| Cohort 2 - Vonoprazan 20 mg | Frequency of Adverse Events | Not Related | 2 participants |
| Cohort 2 - Rabeprazole Sodium 10 mg | Frequency of Adverse Events | Not Related | 1 participants |
| Cohort 2 - Rabeprazole Sodium 10 mg | Frequency of Adverse Events | Related | 0 participants |
| Cohort 2 - Rabeprazole Sodium 10 mg | Frequency of Adverse Events | Mild | 1 participants |
| Cohort 2 - Rabeprazole Sodium 10 mg | Frequency of Adverse Events | Treatment Emergent Adverse Events | 1 participants |
| Cohort 2 - Rabeprazole Sodium 10 mg | Frequency of Adverse Events | Leading to Study Drug Discontinuation | 0 participants |
| Cohort 2 - Rabeprazole Sodium 10 mg | Frequency of Adverse Events | Severe | 0 participants |
| Cohort 2 - Rabeprazole Sodium 10 mg | Frequency of Adverse Events | Moderate | 0 participants |
Secondary
Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings
Time frame: At Screening, baseline (Day -3), administration period (Day 8), and post-test (Day 28)
Population: Safety analysis set - All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 - Vonoprazan 20 mg | Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings | 0 participants |
| Cohort 1 - Esomeprazole 20 mg | Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings | 0 participants |
| Cohort 2 - Vonoprazan 20 mg | Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings | 0 participants |
| Cohort 2 - Rabeprazole Sodium 10 mg | Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings | 0 participants |
Secondary
Number of Participants With Abnormal Changes From Baseline in Vital Signs
Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).
Time frame: At screening, baseline (Day -3, Day -2, Day -1), administration period (Days 1, Day 2, Day 7, Day 8), and post-test (Day 28)
Population: Safety analysis set - All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 - Vonoprazan 20 mg | Number of Participants With Abnormal Changes From Baseline in Vital Signs | 0 participants |
| Cohort 1 - Esomeprazole 20 mg | Number of Participants With Abnormal Changes From Baseline in Vital Signs | 0 participants |
| Cohort 2 - Vonoprazan 20 mg | Number of Participants With Abnormal Changes From Baseline in Vital Signs | 0 participants |
| Cohort 2 - Rabeprazole Sodium 10 mg | Number of Participants With Abnormal Changes From Baseline in Vital Signs | 0 participants |
Secondary
Number of Participants With Markedly Abnormal Laboratory Values
The number of participants with markedly abnormal laboratory values for Chemistry, Hematology and Urinalysis during the study is reported.
Time frame: At Screening, baseline (Day -3), administration period (Day 1, Day 8), and post-test (Day 28)
Population: Safety analysis set - All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 - Vonoprazan 20 mg | Number of Participants With Markedly Abnormal Laboratory Values | 0 participants |
| Cohort 1 - Esomeprazole 20 mg | Number of Participants With Markedly Abnormal Laboratory Values | 0 participants |
| Cohort 2 - Vonoprazan 20 mg | Number of Participants With Markedly Abnormal Laboratory Values | 0 participants |
| Cohort 2 - Rabeprazole Sodium 10 mg | Number of Participants With Markedly Abnormal Laboratory Values | 0 participants |