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NCT Number: NCT07792408

Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.

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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

About this study

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives. 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.

Key Inclusion Criteria:

  • Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m^2), inclusive
  • A total body weight of greater than (>) 50 kg

Key Exclusion Criteria:

  • History of febrile illness within 5 days before the first dose of study drug
  • Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug

Other protocol defined Inclusion/Exclusion criteria will apply.

Treatment and study plan

VX-407

Drug

Tablets 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/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 B (Optional): Maximum Observed Plasma Concentration (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

  3. Part C (Optional): Maximum Observed Plasma Concentration (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

  4. Part D (Optional): Maximum Observed Plasma Concentration (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

  5. Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG/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

  6. Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) 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

  7. Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (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

  8. Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (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 39

  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: Maximum Observed Plasma Concentration (Cmax) of VX-407

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

  6. Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

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

  7. Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

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

  8. Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

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

  9. Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

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

  10. Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

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

  11. Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

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

  12. Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

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

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

617-341-6777

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 1, Open-label Drug Interaction Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 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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