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Autosomal Dominant Polycystic Kidney Disease (ADPKD)Phase 1NCT07792408

Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives

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 Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives. 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
148 participants
Where
1 siteCanada
Study dates
1 Sep 2026to 20 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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), inclusive
  • A total body weight of greater than (>) 50 kg

Who cannot join

  • History of febrile illness within 5 days before the first dose of study drug
  • Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug
  • Other protocol defined Inclusion/Exclusion criteria will apply.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Medical Information contact

617-341-6777

medicalinfo@vrtx.com

Canada1 site, 1 recruiting

  • Altasciences - Beaumont Clinic Montreal

    Montreal

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 1, Open-label Drug Interaction Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.

Read the detailed description

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives. 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
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

    Tablets 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 NCT07792408
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/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 B (Optional): Maximum Observed Plasma Concentration (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

  3. Part C (Optional): Maximum Observed Plasma Concentration (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

  4. Part D (Optional): Maximum Observed Plasma Concentration (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

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

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

  6. Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) 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

  7. Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (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

  8. Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (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 39

  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: Maximum Observed Plasma Concentration (Cmax) of VX-407

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

  6. Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

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

  7. Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

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

  8. Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407

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

  9. Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

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

  10. Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

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

  11. Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407

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

  12. Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (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 posted28 Aug 2026
  2. Study start1 Sep 2026
  3. Primary completion11 Mar 2027 (estimated)
  4. Study completion20 Mar 2027 (estimated)

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
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07792408
Sponsor's protocol ID
VX26-407-014
Status last verified
Sep 2026
First submitted
25 Aug 2026
Last updated
30 Sep 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/our-science/clinical-trials-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 Canada.

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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Sep 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Medical Information (617-341-6777, medicalinfo@vrtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/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 NCT07792408.

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 Sep 2026.

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