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

Sponsor
Institut de Recherches Internationales Servier (I.R.I.S.)
Study ID
NCT07235748
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 7, 2025
Status verified
Feb 2026
Primary completion
Dec 23, 2025
Completion
Dec 23, 2025

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Vorasidenib and cytochrome P450 and transporter index substrates
    Participants will receive a single oral dose of 50mg flurbiprofen, 20mg omeprazole, 2mg midazolam and 0.5mg repaglinide on Day 1, 150mg bupropion on Day 2, and 10mg rosuvastatin on Day 5. Participants will receive an oral daily dose of 40mg vorasidenib from Day 8 to Day 28. In addition, participants will receive a single oral dose of 50mg flurbiprofen, 20mg omeprazole, 2mg midazolam and 0.5mg repaglinide on Day 22, 150mg bupropion on Day 23, and 10mg rosuvastatin on Day 26, co-administered with vorasidenib.

Primary Outcome Measure

Maximum concentration (Cmax) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin [ Time Frame: Through Day 29 ]

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