Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants

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.