Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants
NCT ID: NCT07074327
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
148 participants
INTERVENTIONAL
2025-07-11
2026-07-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE)
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.
VX-407
Suspension for oral administration.
LNG/EE
Combination Tablets for Oral Administration.
Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE)
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.
VX-407
Suspension for oral administration.
NGM/EE
Combination Tablets for Oral Administration.
Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE)
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.
VX-407
Suspension for oral administration.
NET/EE
Combination Tablets for Oral Administration.
Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)
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.
VX-407
Suspension for oral administration.
DRSP/EE
Combination Tablets for Oral Administration.
Interventions
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VX-407
Suspension for oral administration.
LNG/EE
Combination Tablets for Oral Administration.
NGM/EE
Combination Tablets for Oral Administration.
NET/EE
Combination Tablets for Oral Administration.
DRSP/EE
Combination Tablets for Oral Administration.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Altasciences - Kansas City
Overland Park, Kansas, United States
Countries
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Central Contacts
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Other Identifiers
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VX24-407-006
Identifier Type: -
Identifier Source: org_study_id
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