Overview

The aim of the study is to gather information on how the drug behaves in healthy adults, how it is absorbed, and how it interacts when taken with other medicines.

Eligibility

Inclusion Criteria:

1. Participants must be 18 to 60 years of age inclusive at the time of signing the Informed consent form (ICF).
2. Male or female
   1. Male Participants: No restrictions for male participants
   2. A female participant (female sex assigned at birth) is eligible to participate if she is not pregnant, or breastfeeding and the following condition applies: She is a woman of nonchildbearing potential (WONCBP).
   3. Participants who are overtly healthy as determined by medical evaluation 4. AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) 6. Capable of giving signed informed consent.

      Exclusion Criteria:

      1. History or presence of clinical conditions affecting drug absorption, metabolism, or elimination.,
      2. Pre-existing clinically relevant, gastro-intestinal pathology
      3. Abnormal glucose metabolism requiring insulin or medications.
      4. Abnormal blood pressure.
      5. History of Lymphoma, leukemia, or any malignancy within the past 5 years (3 years for resected basal or squamous epithelial carcinomas of skin).
      6. Breast cancer within the past 10 years.
      7. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
      8. Medical history of cardiac arrhythmias or cardiac disease or a family long QT syndrome.
      9. History of seizure(s) and / or other neurological conditions.
      10. Pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and / or suicidal ideation.
      11. History of drug hypersensitivity.
      12. Use of medications/supplements affecting cytochrome P450 enzymes within 7 to 14 days prior to dosing.
      13. Contraindications based on selected drug prescribing information. 15. Exposure to more than 4 new investigational products within 12 months 16. Current enrollment or past participation in another investigational study in which an investigational intervention was administered within the last 30 days.
      14. Estimated glomelular filtration rate (eGFR) < 90 mL/min or serum creatinine >1.1×ULN [Inker, 2021].
      15. Hemoglobin <12.5 g/dL for men and <11 g/dL for women. 19. Presence of Hepatitis B surface antigen (HBsAg) [and Hepatitis B core antibody (HBcAb)] at screening 20. Positive Hepatitis C antibody test result at screening AND positive on reflex to Hepatitis C RNA 21. Positive SARS-CoV-2 test, having signs and symptoms which in the opinion of the investigator are suggestive of COVID-19.

     22.Positive pre- study drug/alcohol screen. 23. Poor metabolizers of CYP2C9 and / or
     CYP2C19 as assessed by genotype testing. HLA-B*1502 positive as applicable to
     specified cohort.
     Other exclusion criteria 24. Regular alcohol consumption exceeding specified limits.
     25. Regular use of known drugs of abuse. 26. Nicotine use within 6 months. 27.
     Sensitivity or allergy to the study drug. 28. ALT >1.5×ULN. 29. Total bilirubin
     >1.5×ULN. 30. Significant arrhythmias or ECG findings that may compromise
     participant safety according to the investigator or VH Medical Monitor's assessment.
     31. For eligibility determination, triplicate ECGs are required. The criteria are:
       -  Heart Rate: Excludes males with <45 or >100 bpm, females with <50 or >100 bpm.
       -  PR Interval: Excludes any PR intervals <120 or >220 msec.
       -  QRS Duration: Excludes durations <70 or >120 msec.
       -  QTcF Interval: Excludes intervals >450 msec.