NCT07235748

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

A Phase 1, Open-label, Single-sequence, 2-period Study to Evaluate the Effect of Multiple Doses of Vorasidenib on the Pharmacokinetics of a Single Dose of Sensitive Index Substrates of Cytochrome P450 2B6, 2C8, 2C9, 2C19, 3A4, and Breast Cancer Resistance Protein in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.) · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult Participants

Interventions

Type	Name	Description
DRUG	Vorasidenib	40mg taken orally daily from Day 8 through Day 28
DRUG	Bupropion	150mg taken orally on Day 2 and Day 23
DRUG	Flurbiprofen	50mg taken orally on Day 1 and Day 22
DRUG	Omeprazole	20mg taken orally on Day 1 and Day 22
DRUG	Midazolam	2mg taken orally on Day 1 and Day 22
DRUG	Repaglinide	0.5mg taken orally on Day 1 and Day 22
DRUG	Rosuvastatin	10mg taken orally on Day 5 and Day 26

Timeline

• Start date: 2025-10-07
• Primary completion: 2025-12-23
• Completion: 2025-12-23
• First posted: 2025-11-19
• Last updated: 2026-02-17

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study