NCT07235774

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

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.) · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult Female Participants

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-05
• Primary completion: 2026-03-13
• Completion: 2026-03-13
• First posted: 2025-11-19
• Last updated: 2026-03-16

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study