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

NCT07235748 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-02-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier (I.R.I.S.)

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-07
Primary Completion
2025-12-23
Completion
2025-12-23
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07235748 on ClinicalTrials.gov