Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ViiV Healthcare
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
1. History or presence of clinical conditions affecting drug absorption, metabolism, or elimination.,
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. History of syncope, clinically significant palpitations, cardiac arrhythmias or cardiac disease or a family long QT syndrome.
9. History of seizure(s) and / or other clinically significant neurological conditions.
10. Pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and / or suicidal ideation.
11. History of drug hypersensitivity.
13\. Use of medications/supplements affecting cytochrome P450 enzymes within 7 to 14 days prior to dosing.
14\. 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.
18\. 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.
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.
Clareo Health | A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults
