Vorasidenib - Combined Oral Contraceptive PK, safety and tolerability study
Research type
Research Study
Full title
A Phase 1, open-label, single-sequence, 2-period study to determine the effects of repeated oral dosing of vorasidenib on the pharmacokinetics, safety and tolerability of a combined oral contraceptive in healthy female participants.
IRAS ID
1012739
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 might impact the way the body interacts with the birth control pill.
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.
The other aims of this study are to:
• learn about the safety and tolerability of multiple doses of vorasidenib when taken alone and when taken with an approved birth control pill
• and to learn how much vorasidenib is in the blood after taking multiple doses.
Participants will take the study drugs during one in-house stay at the clinical site.
The total duration of the study for each participant will be up to 83 days; consisting of a screening period of up to 27 days, an in-house period of up to 26 days, and a follow-up period of up to 30 days.
The study drugs will be given during two treatment periods while they are at the study site:
• During the first treatment period, they will receive a single dose of the birth control tablet.
• During the second treatment period, they will again receive a single dose of the birth control tablet in addition to a daily dose of vorasidenib.REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0674
Date of REC Opinion
4 Nov 2025
REC opinion
Further Information Favourable Opinion