A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults

Korábbi kezelés

• Use of medications/supplements affecting cytochrome P450 enzymes within 7 to 14 days prior to dosing.
• 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.

Más betegség

• History or presence of clinical conditions affecting drug absorption, metabolism, or elimination.,
• History of Lymphoma, leukemia, or any malignancy within the past 5 years (3 years for resected basal or squamous epithelial carcinomas of skin).
• Breast cancer within the past 10 years.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities.
• History of seizure(s) and / or other clinically significant neurological conditions.
• Pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and / or suicidal ideation.
• History of drug hypersensitivity.
• Heart Rate: Excludes males with <45 or >100 bpm, females with <50 or >100 bpm.

Laborértékek

• Abnormal glucose metabolism requiring insulin or medications.
• History of syncope, clinically significant palpitations, cardiac arrhythmias or cardiac disease or a family long QT syndrome.
• Estimated glomelular filtration rate (eGFR) < 90 mL/min or serum creatinine >1.1×ULN [Inker, 2021].
• 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 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.

Egyéb

• Pre-existing clinically relevant, gastro-intestinal pathology
• Clinically significant Abnormal blood pressure.
• For eligibility determination, triplicate ECGs are required. The criteria are:
• PR Interval: Excludes any PR intervals <120 or >220 msec.
• QRS Duration: Excludes durations <70 or >120 msec.
• QTcF Interval: Excludes intervals >450 msec.

• Participants must be 18 to 60 years of age inclusive at the time of signing the Informed consent form (ICF).
• Male or female
• Male Participants: No restrictions for male participants
• 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).
  • 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.