A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants
Status:
RECRUITING
Trial end date:
2026-03-14
Target enrollment:
Participant gender:
Summary
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.
Phase:
PHASE1
Details
Lead Sponsor:
Institut de Recherches Internationales Servier (I.R.I.S.)