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Completed

NCT Number: NCT07074327

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

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.

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences - Kansas City

Overland Park, Kansas, 66212, United States

About this study

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-407

Drug

Suspension for oral administration.

LNG/EE

Drug

Combination Tablets for Oral Administration.

NGM/EE

Drug

Combination Tablets for Oral Administration.

NET/EE

Drug

Combination Tablets for Oral Administration.

DRSP/EE

Drug

Combination Tablets for Oral Administration.

Primary outcomes

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

    Time frame: From Day 1 up to Day 7 and Day 21 up to Day 27

  2. 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

    Time frame: From Day 1 up to Day 7 and Day 21 up to Day 27

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

    Time frame: From Day 1 up to Day 9 and Day 23 up to Day 31

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

    Time frame: From Day 1 up to Day 9 and Day 23 up to Day 31

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

    Time frame: From Day 1 up to Day 5 and Day 19 up to Day 23

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

    Time frame: From Day 1 up to Day 5 and Day 19 up to Day 23

  7. Part D (Optional): Cmax of DRSP and EE in the Absence and Presence of VX-407

    Time frame: From Day 1 up to Day 7 and Day 21 up to Day 27

  8. Part D (Optional): AUC0-inf of DRSP and EE in the Absence and Presence of VX-407

    Time frame: From Day 1 up to Day 7 and Day 21 up to Day 27

Secondary outcomes

  1. Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Day 1 up to Day 36

  2. Part B (Optional): Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Day 1 up to Day 40

  3. Part C (Optional): Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Day 1 up to Day 32

  4. Part D (Optional): Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Day 1 up to Day 36

  5. Part A: Cmax of VX-407

    Time frame: Days 9, 15 and 21 up to Day 27

  6. Part A: AUC0-inf of VX-407

    Time frame: Days 9, 15 and 21 up to Day 27

  7. Part B (Optional): Cmax of VX-407

    Time frame: Days 11, 17 and 23 up to Day 31

  8. Part B (Optional): AUC0-inf of VX-407

    Time frame: Days 11, 17 and 23 up to Day 31

  9. Part C (Optional): Cmax of VX-407

    Time frame: Days 7, 13 and 19 up to Day 23

  10. Part C (Optional): AUC0-inf of VX-407

    Time frame: Days 7, 13 and 19 up to Day 23

  11. Part D (Optional): Cmax of VX-407

    Time frame: Days 9, 15 and 21 up to Day 27

  12. Part D (Optional): AUC0-inf of VX-407

    Time frame: Days 9, 15 and 21 up to Day 27

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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