Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants
Summary
The objective of this study is to evaluate the effect of multiple doses of vorasidenib on single-dose PK of bupropion as an index substrate of CYP2B6, flurbiprofen as an index substrate of CYP2C9, omeprazole as an index substrate of CYP2C19, repaglinide as an index substrate of CYP2C8, midazolam as an index substrate of CYP3A4, and rosuvastatin as a substrate of BCRP in healthy adult participants. The study consists of screening, two treatment periods in-house, and a follow-up period. During the first period, Day 1 through Day 7, participants will receive CYPs and BCRP index substrates alone and during the second treatment period, Day 8 through Day 28, these will be administered in combination with vorasidenib. Participation in the study will be up to 87 days from screening through the follow up period. Study activities may include blood tests, ECG, vital signs, and a physical examination.
Timeline
- Start
- 2025-10-07
- Primary completion
- 2025-12-23
- Completion
- 2025-12-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | 150 mg | Oral |
| Subject | Flurbiprofen | Small molecule | 50 mg | Oral |
| Subject | Midazolam | Small molecule | 2 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 20 mg | Oral |
| Subject | Repaglinide | Small molecule | 0.5 mg | Oral |
| Subject | Rosuvastatin | Small molecule | 10 mg | Oral |
| Subject | Vorasidenib | Small molecule | 40 mg | Oral |
Indications
No indication recorded.