Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants

Inclusion criteria

• Healthy male or non-pregnant, non-lactating female participants, including women of childbearing potential (WOCBP).
• Body mass index (BMI) of 18.0 - 30.0 kg/m² (both inclusive), at Screening.
• Body weight of at least 40 kg, at Screening.
• Female participants of childbearing potential must use 2 effective methods of birth control, or abstinence from Screening until at least 90 days after the last dose of vorasidenib; be surgically sterile at least 6 months prior to the first dose of investigational medicinal product (IMP) in the study; or be postmenopausal. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and prior to the first dose of IMP in the study.
• Male participants with female partners of childbearing potential must be sterile, be willing to use 2 effective methods of birth control from Screening until at least 90 days after the last dose of vorasidenib, or practice abstinence from Screening until at least 90 days after the last dose of vorasidenib. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the participant. Male participants should also agree to not donate sperm for the duration of the study and until at least 90 days after the last dose of vorasidenib.
• The participant is a continuous nonsmoker who has not used nicotine-containing products (e.g., snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) for at least 3 months prior to the first dose of IMP in the study based on a cotinine test result.
• The participant is considered by the investigator (or designee, if applicable) to be in good general health as determined by medical history, full physical examination, clinical laboratory test results, 12-lead electrocardiogram (ECG) results, and vital sign measurements findings at screening and admission.

Exclusion criteria

• The participant is a WOCBP who is pregnant, lactating, or planning to become pregnant within at least 90 days after the last dose of vorasidenib in the study; the participant is on oral contraceptive pills or contraceptive patch within 14 days or 5 half-lives (whichever is longer) prior to the first dose of IMP in the study; the participant used a hormonal IUD or vaginal ring within 3 months prior to the first dose of IMP in the study; or the participant received any injectable or implantable hormone-containing product within 1 year prior to the first dose of IMP in the study.
• The participant has consumed grapefruit or grapefruit juice or Seville orange or Seville orange-containing products (e.g., marmalade) within 14 days prior to the first dose of IMP in the study.
• The participant has ingested vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) and charbroiled meats within 14 days prior to the first dose of IMP in the study.
• The participant has consumed caffeine- or xanthine-containing products (e.g., coffee, tea, cola drinks, and chocolate), alcohol, or products containing any of these within 48 hours prior to the first dose of IMP in the study.
• The participant is unable or unwilling to abstain from recreational drugs, alcohol, caffeine, xanthine-containing beverages or food (e.g., coffee, tea, chocolate, and caffeinated sodas, colas), grapefruit, grapefruit juice, Seville oranges, or products containing any of these, from 48 hours (caffeine, xanthine-containing beverages or food, alcohol) or 14 days (recreational drugs, grapefruit, grapefruit juice, Seville oranges, or Seville orange-containing products) prior to the first dose of IMP in the study until the Discharge/Early Termination visit.
• The participant has received any vaccine or used any prescription (including hormonal birth control or hormone replacement therapy) or over-the-counter medications (except acetaminophen/paracetamol [up to 2 g per 24 hours] or ibuprofen [up to 1.2 g per 24 hours]), including herbal (e.g., St. John's Wort) or nutritional supplements, within 14 days or 5 drug half-lives, whichever is longer, prior to the first dose of IMP in the study.