RECRUITING

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

Talk to us

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)Oral contraceptivesDrug interactionPharmacokinetics

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-07-11
Study Completion:2026-07-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07074327

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m\^2)
  2. * A total body weight of greater than (\>) 50 kg
  3. * Nonsmoker or ex-smoker for at least 12 months before screening
  4. * 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)
  1. * History of febrile illness within 5 days before the first dose of study drug
  2. * 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
  3. * Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
  4. * Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug
  5. * Menopausal, post-menopausal, or documented bilateral oophorectomy and/or hysterectomy
  6. * Previously received study drug in this study

Contacts and Locations

Study Contact

Medical Information
CONTACT
617-341-6777
medicalinfo@vrtx.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Vertex Pharmaceuticals Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-11
Study Completion Date2026-07-04

Study Record Updates

Study Start Date2025-07-11
Study Completion Date2026-07-04

Terms related to this study

Keywords Provided by Researchers

  • Oral contraceptives
  • Drug interaction
  • Pharmacokinetics

Additional Relevant MeSH Terms

  • Autosomal Dominant Polycystic Kidney Disease (ADPKD)