Vorasidenib - DDI study with Cytochrome P450 and transporter index substrates
Research type
Research Study
Full title
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.
IRAS ID
1012666
Contact name
Valerie Brunet
Contact email
Sponsor organisation
Institut de Recherches Internationales Servier (I.R.I.S.)
Research summary
The main aim of this study is to find out how the study drug vorasidenib affects the levels of certain drugs in the blood. These drugs are known as substrates of proteins called cytochrome P450 (CYP) 2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and breast cancer resistance protein (BCRP). These proteins help move drugs through the body and break them down or remove them from the body.
Vorasidenib (also known as S095032, AG-881, or VORANIGO®) is a drug being developed by the sponsor to treat people with glioma, a type of brain cancer.
During the study, participants will be given approved drugs: bupropion (processed by CYP2B6), repaglinide (CYP2C8), flurbiprofen (CYP2C9), omeprazole (CYP2C19), midazolam (CYP3A4), and rosuvastatin (BCRP). The study doctors will check how vorasidenib may affect how the body processes these drugs.
Another aim of this study is to learn how safe it is to take several doses of vorasidenib, both on its own and together with the above-mentioned drugs. The study will also check how well people tolerate taking vorasidenib with and without these other drugs.
Participants will take the study drugs during two in-house treatment periods.
Total duration of study participation for each participant will be up to 87 days; consisting of a screening period of up to 27 days, an in-house period of up to 30 days, and a follow-up period of up to 30 days.During the first treatment period, participants will receive single doses of bupropion, flurbiprofen, omeprazole, midazolam, repaglinide, and rosuvastatin. The second treatment period will occur immediately after the first period. During the second treatment period, participants will again receive single doses of bupropion, flurbiprofen, omeprazole, midazolam, repaglinide, and rosuvastatin in addition to a daily dose of vorasidenib.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0278
Date of REC Opinion
29 Sep 2025
REC opinion
Further Information Favourable Opinion