A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001

Exclusion Criteria

• •・All Participants (Cohorts 1 to 4)
• •1. Participant has a history or presence of hypersensitivity or idiosyncratic reaction to any components of the KP-001 formulation or any components of formulation used as study intervention during the study.
• •2. Participant has a complication of drug allergies or history of drug allergies, or psychiatric disorder as determined by the Investigator or designee.
• •3. Participant used any investigational drug in the last 30 days or 5 half-lives (if known), whichever is longer, prior to Day -1 of Treatment Period.
• •4. Female participant has a positive pregnancy test or is lactating.
• •5. Participant has positive urine drug or urine alcohol and positive cotinine test results at screening or Day -1 of Treatment Period.
• •6. Participant who cannot administer drugs orally.
• •7. Participant is unable or unwilling to undergo multiple venipunctures.
• •8. Participant underwent blood donation or transfusion within 56 days prior to Day -1 of Treatment Period.
• •9. Participant has consumed alcohol- or caffeine-containing foods and beverages within 72 hours prior to Day -1 of Treatment Period and does not agree to refrain from consuming during the entire study, unless deemed acceptable by the Investigator.
• •10. Participant has consumed grapefruit-containing foods and beverages within 7 days prior to Day -1 of Treatment Period and does not agree to refrain from consuming during the entire study.
• •11. Participant has consumed St. John's wort-containing foods and beverages within 14 days prior to Day -1 of Treatment Period and does not agree to refrain from consuming during the entire study.
• •12. Participated in strenuous exercise from 48 hours prior to Check-in (Day -1) or during the study through the final end of study assessment.
• •13. Participant is legally, mentally or physically incapacitated or, in the opinion of the Investigator, has significant mental or emotional problems, including psychiatric illness (e.g., depression and/or anxiety) at the time of the Screening Visit, or that could reasonably be expected to develop during the conduct of the study.
• •14. Participant had any laboratory abnormality that, in the judgment of the Investigator, would put the participant at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
• •15. Participant has abnormal findings on the screening ECG deemed clinically significant by the Investigator or qualified designee.
• •16. Participant is an employee of the Sponsor or any CRO involved in the study, the Investigator, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee involved in the study.
• •17. Any other reason that would render the participant unsuitable for study enrollment at the discretion of the Investigator.
• •18. A participant who has received proton pump inhibitors (PPIs), histamine type-2 (H2)-receptor antagonists, or antacids during the 5-day period immediately preceding and including the admission day (or for 5 half-lives of the medication whichever is longer), or plan to receive any of these medications during treatment period (ie, until Day 3 \[Discharge\]).
• •・Healthy Participants with Normal Hepatic Function (Cohort 1)
• •19. Participant has a significant history or clinical manifestation of any metabolic, allergic, dermatologic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder as determined by the Investigator or designee.
• •20. Participant has a history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
• •21. Participant had any major illness within 30 days before the Screening Visit.
• •22. Participant had any major surgical procedure within 30 days prior to Day -1 of Treatment Period or any planned surgery during study period.
• •23. Participant has a history or presence of liver disease or cholecystectomy within one year prior to screening.
• •24. Participant has a disorder or any condition that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
• •25. Participant used any prescription or non-prescription medications (including vitamins, recreational drugs, and dietary or herbal supplements) within 14 days or 5 half-lives (whichever is longer) prior to Day -1 of Treatment Period and until completion of the Followup Visit unless, in the opinion of the Investigator, may be treatment for an AE or will not interfere with the interpretation of safety.
• •・Participants with Hepatic Impairment (Cohorts 2 to 4)
• •26. Participant with any concomitant disease or condition considered clinically significant that, in the opinion of the investigator, may interfere with the investigational product, pose an unacceptable risk to the participant, or significantly increase the risk to the integrity or utility of the trial data (including treatment of such conditions).
• •27. Participant with acute or chronic conditions other than liver (including, but not limited to, poorly controlled diabetes and grade 3 or higher encephalopathy) that, in the opinion of the investigator, would limit the participant\'s ability to complete the study and/or participate in this study.
• •28. Participant with acute exacerbation of liver dysfunction or unstable liver function as determined by the investigator by Day 1 from screening.
• •29. Participant who is positive for HBsAg, hepatitis C or HIV at screening. Participants with hepatitis C will also be accepted if, in the investigator\'s judgement, they are clinically stable and not receiving active treatment.