RECRUITING

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

Description

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
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Related Conditions:

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Intervention / Treatment

-

Contacts and Locations

Overland Park

Altasciences - Kansas City, Overland Park, Kansas, United States, 66212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Vertex Pharmaceuticals Incorporated,

Study Record Dates

2026-07-04