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RECRUITING
NCT07235774
PHASE1

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

Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.)

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Open-label, Single-sequence, 2-period Study to Determine the Effects of Repeated Oral Dosing of Vorasidenib on the Pharmacokinetics, Safety and Tolerability of a Combined Oral Contraceptive in Healthy Female Participants.

Key Details

Gender

FEMALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-11-05

Completion Date

2026-03-13

Last Updated

2026-03-16

Healthy Volunteers

Yes

Interventions

DRUG

Vorasidenib

40mg taken orally daily from Day 6 through Day 24

DRUG

DRSP/EE

3 mg DRSP/0.02 mg EE taken orally on Day 1 and Day 20

Locations (1)

Celerion

Belfast, Northern Ireland, United Kingdom