Clinical Trial: NCT07235748
Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Institut de Recherches Internationales Servier (I.R.I.S.) |
| Information Provided By: | Servier |
| Last Update Posted: | 2026-02-17 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Vorasidenib
- Drug: Bupropion
- Drug: Flurbiprofen
- Drug: Omeprazole
- Drug: Midazolam
- Drug: Repaglinide
- Drug: Rosuvastatin
Other Study ID Numbers
- S095032-230
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Institut de Recherches Internationales Servier (I.R.I.S.) |
| Information Provided By: | Servier |
| Last Update Posted: | 2026-02-17 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Vorasidenib
- Drug: Bupropion
- Drug: Flurbiprofen
- Drug: Omeprazole
- Drug: Midazolam
- Drug: Repaglinide
- Drug: Rosuvastatin
Other Study ID Numbers
- S095032-230