VX-407 for Oral Contraceptive Interaction Study

Overseen By Medical Information

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Pregnancy, Menopause, Drug absorption issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

148 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the new treatment, VX-407, interacts with various oral contraceptives, including those containing levonorgestrel, norgestimate, norethindrone, or drospirenone. The primary aim is to assess the safety of VX-407 when combined with these contraceptives and its impact on their levels in the body. Ideal participants are non-smokers who have not recently used oral contraceptives and do not have conditions affecting drug metabolism. As a Phase 1 trial, this research seeks to understand how VX-407 functions in people, offering participants the chance to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires participants to stop taking oral contraceptives for a washout period (time without taking certain medications) of 28 days or 5 half-lives, whichever is greater, before starting the study. If you are using Depo-Provera, a 6-month washout is needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VX-407 is being tested for safety when used with different birth control pills. This trial involves healthy individuals who can safely take these contraceptives. So far, no specific reports of side effects have emerged from using VX-407 with these contraceptives.

As an early-phase trial, researchers are beginning to test VX-407 in humans. These trials primarily focus on safety and how well participants tolerate the treatment. Participants are closely monitored for any side effects. Although specific results from the trial are not yet available, reaching this stage suggests some initial confidence in its safety. However, monitoring for any new findings remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about VX-407 because it offers a fresh approach to understanding how new medications interact with commonly used oral contraceptives like Levonorgestrel/Ethinyl Estradiol, Norgestimate/Ethinyl Estradiol, Drospirenone/Ethinyl Estradiol, and Norethindrone/Ethinyl Estradiol. Unlike existing treatments that focus solely on contraceptive efficacy, VX-407 explores potential interactions that could optimize or affect the effectiveness of birth control pills. This study aims to provide insights into how VX-407, when combined with these contraceptives, could lead to more informed choices and improved safety for users. Researchers hope that these findings will enhance contraceptive options and minimize unexpected drug interactions.

What evidence suggests that this trial's treatments could be effective?

Researchers are studying how VX-407 affects birth control pills. This trial includes separate treatment arms to examine VX-407's interaction with different hormones in these pills, such as levonorgestrel, norgestimate, norethindrone, and drospirenone, each combined with ethinyl estradiol. With limited information from human studies on VX-407, the primary focus is to understand its mechanism. The goal is to determine if VX-407 alters the absorption, distribution, or metabolism of these hormones, potentially impacting the effectiveness of the birth control pills. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can safely take oral contraceptives. Participants should not have polycystic kidney disease or any other condition that might interfere with the study's safety and objectives.

Inclusion Criteria

I have not smoked for at least a year.

Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m^2)

I weigh more than 50 kg.

Exclusion Criteria

Previously received study drug in this study

I have not had a fever or flu-like illness in the last 5 days.

I have conditions that make estrogen therapy risky for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single dose of LNG/EE on Days 1 and 21, and VX-407 every 12 hours from Days 8 through 26 in fasted state

4 weeks

Multiple visits for dosing and monitoring

Treatment Part B (Optional)

Participants receive a single dose of NGM/EE on Days 1 and 23, and VX-407 every 12 hours from Days 10 through 30 in fasted state

4 weeks

Multiple visits for dosing and monitoring

Treatment Part C (Optional)

Participants receive a single dose of NET/EE on Days 1 and 19, and VX-407 every 12 hours from Days 6 through 22 in fasted state

3 weeks

Multiple visits for dosing and monitoring

Treatment Part D (Optional)

Participants receive a single dose of DRSP/EE on Days 1 and 21, and VX-407 every 12 hours from Days 8 through 26 in fasted state

4 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VX-407

Trial Overview The study is testing how VX-407 affects the body's handling of different oral contraceptives containing levonorgestrel, norgestimate, norethindrone, drospirenone combined with ethinyl estradiol. It also assesses the safety of taking VX-407 with these contraceptives.

How Is the Trial Designed?

Group I: Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE) Experimental Treatment 2 Interventions

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.

Group II: Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE) Experimental Treatment 2 Interventions

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.

Group III: Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE) Experimental Treatment 2 Interventions

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.

Group IV: Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07074327

Study Details | NCT07074327 | Effects of VX-407 on the ... 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) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07074327?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BLeadSponsorName%5D(vertex))))&rank=1

Effects of VX-407 on the Pharmacokinetics of Oral ... 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) ...

3. tipranks.com tipranks.com/news/company-announcements/vertex-pharmaceuticals-vx-407-study-a-potential-game-changer-in-oral-contraceptive-pharmacokinetics

Vertex Pharmaceuticals' VX-407 Study: A Potential Game ... The study aims to assess how VX-407 affects the pharmacokinetics of various oral contraceptives, including levonorgestrel, norgestimate, ...

4. withpower.com withpower.com/clinical-trials/for-polycystic-kidney-disease

Top Polycystic Kidney Disease Clinical Trials | Power 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 ...

5. synapse.patsnap.com synapse.patsnap.com/drug/dda2d04ad95f4203a95040b938f1ed41

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

6. withpower.com withpower.com/trial/phase-1-polycystic-kidney-autosomal-dominant-6-2025-2f849

VX-407 for Oral Contraceptive Interaction Study This trial is for healthy individuals who can safely take oral contraceptives. Participants should not have polycystic kidney disease or any other condition ...

7. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/VRTX/pressreleases/35739098/vertex-pharmaceuticals-vx-407-study-a-potential-game-changer-in-oral-contraceptive-pharmacokinetics/

Vertex Pharmaceuticals' VX-407 Study: A Potential Game ... This research is significant as it evaluates both the safety and tolerability of VX-407 in combination with these contraceptives, potentially ...