Recruiting
Phase 1

VX-407 with Oral Contraceptives

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT07792408

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

VX-407

LNG/EE

NGM/EE

NET/EE

DRSP/EE

Study Details

Brief summary:

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

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study ID

NCT07792408

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Mar 20, 2027

Anticipated

Primary completion date

Mar 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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.

Study Design

Enrollment

148 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

VX-407

Tablets 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.

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 ]
  • 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 [ Time Frame: From Day 1 up to Day 9 and Day 23 up to Day 31 ]
  • Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of NET and EE in the Absence and Presence of VX-407 [ Time Frame: From Day 1 up to Day 5 and Day 19 up to Day 23 ]
  • Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of DRSP 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 ]
  • 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 [ Time Frame: From Day 1 up to Day 7 and Day 21 up to Day 27 ]
  • 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 [ Time Frame: From Day 1 up to Day 9 and Day 23 up to Day 31 ]
  • 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 [ Time Frame: From Day 1 up to Day 5 and Day 19 up to Day 23 ]
  • 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 [ Time Frame: From Day 1 up to Day 7 and Day 21 up to Day 27 ]

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777medicalinfo@vrtx.com

Locations

Altasciences - Beaumont Clinic Montreal

Recruiting

Montreal, Canada

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.