Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants

Completed · Phase 1

Conditions studied: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

In brief

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.

Key facts

Study ID

NCT07074327

Run by

Vertex Pharmaceuticals Incorporated

People needed

74

Starts

2025-07-11

Expected to finish

2026-02-27

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• History of febrile illness within 5 days before the first dose of study drug
• Relative contraindications to hormonal estrogen therapy that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
• Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
• Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug
• Menopausal, post-menopausal, or documented bilateral oophorectomy and/or hysterectomy
• Previously received study drug in this study
• Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Altasciences - Kansas City — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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