| Eligibility |
Inclusion Criteria:
1. The participant is male or female 18 to 45 years of age, inclusive, at Screening.
2. The participant has a BMI 18 to 30 kg/m^2, inclusive, and has a body weight greater
than 50 kg at Screening.
3. The participant is considered by the investigator to be in good general health as
determined by medical history, clinical laboratory test results, vital sign
measurements, 12-lead ECG results, and physical examination findings at Screening.
4. Female participants of childbearing potential who may be sexually active with a non
sterilized male partner must use an acceptable method of birth control (ie, diaphragm
with spermicide, intrauterine device, condom with foam or vaginal spermicide, oral
contraceptives, or abstinence) from the signing of informed consent until 4 weeks
after the last dose of study drug or be surgically sterile (ie, hysterectomy,
bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as
amenorrhea for 12 consecutive months and documented plasma folical stimulating hormone
[FSH] level >40 IU/mL).
5. Female participants must have a negative pregnancy test at Screening and Check-in.
6. The participant agrees to comply with all protocol requirements.
7. The participant is able to provide written informed consent.
Exclusion Criteria:
1. The participant has a history of any clinically significant neurological,
cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological,
hematological, or endocrine disease or other abnormality that may affect the ability
of the participant to participate in the study.
2. The participant has a positive test result for coronavirus disease 2019 (COVID-19),
hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency
virus type 1 or 2 antibodies at Screening.
3. The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
>2 × the upper limit of normal (ULN) or total bilirubin >1.5 × ULN (with the exception
of Gilbert's syndrome) at Screening or Check-in.
4. The participant has serum creatinine >1.2 mg/dL or blood urea nitrogen >20 mg/dL at
Screening or Check-in.
5. The participant has any acute laboratory abnormality at Screening that precludes
participation in the study, in the opinion of the investigator.
6. The participant has a current or chronic history of liver disease or known hepatic or
biliary abnormalities (with the exception of Gilbert's syndrome and asymptomatic
gallstones).
7. The participant has used any prescription (excluding hormonal birth control) or over
the counter medications (including CYP3A4 inducers) except paracetamol (up to 2 g per
day), including herbal or nutritional supplements, within 14 days (or 5 half-lives)
before the first dose of study drug or throughout the study.
8. The participant has consumed grapefruit or grapefruit juice, Seville orange or Seville
orange containing products (eg, marmalade), or other food products that may be CYP3A4
inhibitors (eg, vegetables from the mustard green family [kale, broccoli, watercress,
collard greens, kohlrabi, Brussels sprouts, mustard] and charbroiled meats) within 7
days (or 5 half-lives) before the first dose of study drug or throughout the study.
9. The participant has consumed caffeine- or xanthine containing products within 48 hours
(or 5 half lives) before the first dose of study drug or throughout the study.
10. The participant is a smoker or has used nicotine or nicotine-containing products (eg,
snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6
months before the first dose of study drug.
11. The participant has a history of alcohol abuse or drug addiction within the last year,
excessive alcohol consumption (regular alcohol intake >21 units per week for male
participants and >14 units of alcohol per week for female participants; 1 unit is
equal to approximately 1/2 pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1
measure [25 mL] of spirits), or use of alcohol 48 hours before the first dose of study
drug or throughout the study.
12. The participant has a positive test result for drugs of abuse, alcohol, or cotinine
(indicating active current smoking) at Screening or Check-in.
13. The participant is involved in strenuous activity or contact sports within 24 hours
before the first dose of study drug or throughout the study.
14. The participant has donated blood or blood products >450 mL within 30 days before the
first dose of study drug.
15. The participant has a history of relevant drug and/or food allergies (ie, allergy to
rifampin, vonoprazan, or excipients, or any significant food allergy that could
preclude a standard diet in the clinical unit).
16. The participant has received study drug in another investigational study within 30
days of dosing.
17. Female participant is pregnant or lactating, intends to become pregnant before,
during, or within 4 weeks after participating in this study, or intends to donate ova
during this time period.
18. In the opinion of the investigator, the participant is not suitable for entry into the
study.
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