VX-407 for Oral Contraceptive Interaction
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.
Are You a Good Fit for This Trial?
This trial is for adults with a BMI between 18 and 30, weighing over 50 kg. Participants are likely women who use oral contraceptives and may have polycystic kidney disease.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- VX-407
Trial Overview
The study tests how the new drug VX-407 affects the way different birth control pills (oral contraceptives) work in the body, as well as its safety when taken together.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive a single dose of DRSP/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 q12h from Days 8 through 26 in fasted state.
Participants will receive a single dose of NET/EE on Days 1 and 19 in fasted state. Participants will also receive VX-407 q12h from Days 6 through 22 in fasted state.
Participants will receive a single dose of NGM/EE on Days 1 and 23 in fasted state. Participants will also receive VX-407 q12h from Days 10 through 30 in fasted state.
Participants will receive a single dose of LNG/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 every 12 hours (q12h) from Days 8 through 26 in fasted state.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology
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