Phase 1, Open-label Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Subjects

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1

SUMMARY

The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE, norethindrone (NET) and EE and drospirenone (DRSP) and EE. Also, to evaluate the safety and tolerability of co-administration of VX-407 with LNG/EE, NGM/EE, NET/EE and DRSP/EE.

Eligibility

Participation Requirements

Sex: Female

Minimum Age: 18

Maximum Age: 50

Healthy Volunteers: t

View:

• Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m\^2)

• A total body weight of greater than (\>) 50 kg

• Nonsmoker or ex-smoker for at least 12 months before screening

• Oral contraceptive naïve or able to comply with 28-day or 5 half-lives (whichever is greater) washout before the start of Period 1 (6-month washout for Depo-Provera)

Locations

United States

Kansas

Altasciences - Kansas City

RECRUITING

Overland Park

Contact Information

Primary

Medical Information

medicalinfo@vrtx.com

617-341-6777

Time Frame

Start Date: 2025-07-11

Estimated Completion Date: 2026-07-04

Participants

Target number of participants: 148

Treatments

Experimental: Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE)

Participants will receive a single dose of LNG/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 every 12 hours (q12h) from Days 8 through 26 in fasted state.

Experimental: Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE)

Participants will receive a single dose of NGM/EE on Days 1 and 23 in fasted state. Participants will also receive VX-407 q12h from Days 10 through 30 in fasted state.

Experimental: Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE)

Participants will receive a single dose of NET/EE on Days 1 and 19 in fasted state. Participants will also receive VX-407 q12h from Days 6 through 22 in fasted state.

Experimental: Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)

Participants will receive a single dose of DRSP/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 q12h from Days 8 through 26 in fasted state.

Related Therapeutic Areas

Autosomal Dominant Polycystic Kidney Disease

Polycystic Kidney Disease

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Phase 1, Open-label Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Subjects

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