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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
40mg taken orally daily from Day 6 through Day 24
3 mg DRSP/0.02 mg EE taken orally on Day 1 and Day 20
Celerion
Belfast, Northern Ireland, United Kingdom
RECRUITINGMaximum concentration (Cmax) of DRSP and EE
Time frame: 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
Time frame: Through Day 25
AUC from 0 extrapolated to infinity (AUC0-inf) of DRSP and EE
Time frame: Through Day 25
Time corresponding to Cmax (Tmax) of DRSP and EE
Time frame: Through Day 25
Terminal half-life (t1/2) of DRSP and EE
Time frame: Through Day 25
Apparent oral clearance (CL/F) of DRSP and EE
Time frame: Through Day 25
Apparent volume of distribution during the terminal phase following oral administration (Vz/F) of DRSP and EE
Time frame: Through Day 25
Elimination rate constant (Kel) of DRSP and EE
Time frame: Through Day 25
Number of Adverse Events (AEs)
Time frame: Through the Follow-up Phone Call (Day 53)
Trough plasma concentration (Ctrough) of vorasidenib
Time frame: Through Day 24
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
CONTACT
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