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

Conditions

• Healthy Adult Female Participants

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Vorasidenib — DRUG
  40mg taken orally daily from Day 6 through Day 24
• DRSP/EE — DRUG
  3 mg DRSP/0.02 mg EE taken orally on Day 1 and Day 20

Study Details

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.

Key Dates

Start date

Nov 5, 2025

Status verified

May 2026

Primary completion

Mar 13, 2026

Completion

Mar 13, 2026

Study Design

Enrollment

28 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Vorasidenib and drospirenone (DRSP)/ethinyl estradiol (EE)
  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.

Primary Outcome Measure

Maximum concentration (Cmax) of DRSP and EE [ Time Frame: Through Day 25 ]