A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants

The objective of this study is to evaluate the effect of multiple oral doses of vorasidenib on the single dose pharmacokinetics of the representative combined oral contraceptive, drospirenone (DRSP)/ethinyl estradiol (EE), in healthy female participants. The study includes a screening phase, two treatment periods in-house, and a follow-up period. During the first period, from Day 1 through Day 5, participants will take one dose of DRSP/EE. In the second treatment period, from Day 6 through Day 24, participants will take vorasidenib every day, and on Day 20, they will take DRSP/EE along with vorasidenib. The entire study, including screening and follow-up, will last up to 83 days. Participants may undergo blood tests, heart tests (electrocardiogram (ECG)), vital sign checks, and physical exams.

NCT Number	NCT07235774
Lead Sponsor	Institut de Recherches Internationales Servier (I.R.I.S.)
Conditions	Healthy Adult Female Participants
Enrollment	28 participants
Start Date	2025-11-05
Primary Completion	2026-03-13 (estimated)
Study Completion	2026-03-13 (estimated)
Updated on ClinicalTrials.gov	2026-05-12