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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Unnamed facility
Fukuoka, Fukuoka, Japan
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)
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
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)
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)
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)
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