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.
Age range
18 Years – 55 Years
Sex
FEMALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum concentration (Cmax) of DRSP and EE
Timeframe: Through Day 25
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-last) of DRSP and EE
Timeframe: Through Day 25
AUC from 0 extrapolated to infinity (AUC0-inf) of DRSP and EE
Timeframe: Through Day 25
Time corresponding to Cmax (Tmax) of DRSP and EE
Timeframe: Through Day 25
Terminal half-life (t1/2) of DRSP and EE
Timeframe: Through Day 25
Apparent oral clearance (CL/F) of DRSP and EE
Timeframe: Through Day 25
Apparent volume of distribution during the terminal phase following oral administration (Vz/F) of DRSP and EE
Timeframe: Through Day 25
Elimination rate constant (Kel) of DRSP and EE
Timeframe: Through Day 25