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Autosomal Dominant Polycystic Kidney Disease (ADPKD)Phase 1NCT07074327

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

A Phase 1 study testing VX-407, LNG/EE and NGM/EE in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Vertex Pharmaceuticals Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
What is being tested?
VX-407, LNG/EE and NGM/EE
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
11 Jul 2025to 27 Feb 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Altasciences - Kansas City

    Overland Park, Kansas, 66212

Other trials in United States

About this study

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

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.

Read the detailed description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Being tested
VX-407, LNG/EE, NGM/EE, NET/EE, DRSP/EE
Keywords
Oral contraceptives, Drug interaction, Pharmacokinetics
Medical subject headings
Polycystic Kidney, Autosomal Dominant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VX-407Drug

    Suspension for oral administration.

  • LNG/EEDrug

    Combination Tablets for Oral Administration.

  • NGM/EEDrug

    Combination Tablets for Oral Administration.

  • NET/EEDrug

    Combination Tablets for Oral Administration.

  • DRSP/EEDrug

    Combination Tablets for Oral Administration.

Study groups in NCT07074327
Study groupRoleWhat they receive
Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE)ExperimentalParticipants 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.
Receives: Drug: VX-407; Drug: LNG/EE
Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE)ExperimentalParticipants 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.
Receives: Drug: VX-407; Drug: NGM/EE
Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE)ExperimentalParticipants 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.
Receives: Drug: VX-407; Drug: NET/EE
Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)ExperimentalParticipants 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.
Receives: Drug: VX-407; Drug: DRSP/EE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Maximum Observed Plasma Concentration (Cmax) of LNG and EE in the Absence and Presence of VX-407

    Measured: From Day 1 up to Day 7 and Day 21 up to Day 27

  2. Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG and EE in the Absence and Presence of VX-407

    Measured: From Day 1 up to Day 7 and Day 21 up to Day 27

  3. Part B (Optional): Cmax of Norelgestromin (NGMN) and Norgestrel (NG) (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407

    Measured: From Day 1 up to Day 9 and Day 23 up to Day 31

  4. Part B (Optional): AUC0-inf of NGMN and NG (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407

    Measured: From Day 1 up to Day 9 and Day 23 up to Day 31

  5. Part C (Optional): Cmax of NET and EE in the Absence and Presence of VX-407

    Measured: From Day 1 up to Day 5 and Day 19 up to Day 23

  6. Part C (Optional): AUC0-inf of NET and EE in the Absence and Presence of VX-407

    Measured: From Day 1 up to Day 5 and Day 19 up to Day 23

  7. Part D (Optional): Cmax of DRSP and EE in the Absence and Presence of VX-407

    Measured: From Day 1 up to Day 7 and Day 21 up to Day 27

  8. Part D (Optional): AUC0-inf of DRSP and EE in the Absence and Presence of VX-407

    Measured: From Day 1 up to Day 7 and Day 21 up to Day 27

Secondary outcomes (12)

  1. Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From Day 1 up to Day 36

  2. Part B (Optional): Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From Day 1 up to Day 40

  3. Part C (Optional): Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From Day 1 up to Day 32

  4. Part D (Optional): Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From Day 1 up to Day 36

  5. Part A: Cmax of VX-407

    Measured: Days 9, 15 and 21 up to Day 27

  6. Part A: AUC0-inf of VX-407

    Measured: Days 9, 15 and 21 up to Day 27

  7. Part B (Optional): Cmax of VX-407

    Measured: Days 11, 17 and 23 up to Day 31

  8. Part B (Optional): AUC0-inf of VX-407

    Measured: Days 11, 17 and 23 up to Day 31

  9. Part C (Optional): Cmax of VX-407

    Measured: Days 7, 13 and 19 up to Day 23

  10. Part C (Optional): AUC0-inf of VX-407

    Measured: Days 7, 13 and 19 up to Day 23

  11. Part D (Optional): Cmax of VX-407

    Measured: Days 9, 15 and 21 up to Day 27

  12. Part D (Optional): AUC0-inf of VX-407

    Measured: Days 9, 15 and 21 up to Day 27

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study start11 Jul 2025
  3. Primary completion20 Feb 2026
  4. Study completion27 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07074327
Sponsor's protocol ID
VX24-407-006
Status last verified
Aug 2025
First submitted
9 Jul 2025
Last updated
30 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VX-407, LNG/EE and NGM/EE in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Vertex Pharmaceuticals Incorporated at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Maximum Observed Plasma Concentration (Cmax) of LNG and EE in the Absence and Presence of VX-407 (time frame: From Day 1 up to Day 7 and Day 21 up to Day 27). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07074327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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