CompletedPhase 1

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

United States74 participantsStarted 2025-07-11

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Maximum Observed Plasma Concentration (Cmax) of LNG and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 7 and Day 21 up to Day 27

Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 7 and Day 21 up to Day 27

Part B (Optional): Cmax of Norelgestromin (NGMN) and Norgestrel (NG) (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 9 and Day 23 up to Day 31

Part B (Optional): AUC0-inf of NGMN and NG (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 9 and Day 23 up to Day 31

Part C (Optional): Cmax of NET and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 5 and Day 19 up to Day 23

Part C (Optional): AUC0-inf of NET and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 5 and Day 19 up to Day 23

Trial details

NCT IDNCT07074327

SponsorVertex Pharmaceuticals Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-20

View on ClinicalTrials.gov More Autosomal Dominant Polycystic Kidney Disease (ADPKD) trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part A: Maximum Observed Plasma Concentration (Cmax) of LNG and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 7 and Day 21 up to Day 27

Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 7 and Day 21 up to Day 27

Part B (Optional): Cmax of Norelgestromin (NGMN) and Norgestrel (NG) (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 9 and Day 23 up to Day 31

Part B (Optional): AUC0-inf of NGMN and NG (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 9 and Day 23 up to Day 31

Part C (Optional): Cmax of NET and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 5 and Day 19 up to Day 23

Part C (Optional): AUC0-inf of NET and EE in the Absence and Presence of VX-407

Timeframe: From Day 1 up to Day 5 and Day 19 up to Day 23