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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorasidenib and drospirenone (DRSP)/ethinyl estradiol (EE) | Experimental | Participants will receive a single oral dose of 3 mg DRSP/0.02 mg EE on Day 1. Participants will receive an oral daily dose of 40mg vorasidenib from Day 6 to Day 24. In addition, participants will receive a single oral dose of 3 mg DRSP/0.02 mg EE on Day 20, co-administered with vorasidenib. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorasidenib | Drug | 40mg taken orally daily from Day 6 through Day 24 |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of DRSP and EE | 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 | Through Day 25 | |
| AUC from 0 extrapolated to infinity (AUC0-inf) of DRSP and EE | Through Day 25 | |
| Time corresponding to Cmax (Tmax) of DRSP and EE | Through Day 25 | |
| Terminal half-life (t1/2) of DRSP and EE | Through Day 25 | |
| Apparent oral clearance (CL/F) of DRSP and EE | Through Day 25 | |
| Apparent volume of distribution during the terminal phase following oral administration (Vz/F) of DRSP and EE | Through Day 25 | |
| Elimination rate constant (Kel) of DRSP and EE | Through Day 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) | Through the Follow-up Phone Call (Day 53) | |
| Trough plasma concentration (Ctrough) of vorasidenib | Through Day 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Belfast | Northern Ireland | BT9 6AD | United Kingdom |
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
In addition, access can be requested for all interventional clinical studies in patients:
After Marketing Authorization in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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| ID | Term |
|---|---|
| C000716758 | vorasidenib |
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| DRSP/EE | Drug | 3 mg DRSP/0.02 mg EE taken orally on Day 1 and Day 20 |
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