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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Intervention / Treatment: Drug: DRSP/EE; Drug: NGM/EE; Drug: LNG/EE; Drug: NET/EE; Drug: VX-407

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.).

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Medical Information; Phone Number: 617-341-6777; Email: medicalinfo@vrtx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: LNG/EE; Combination Tablets for Oral Administration.; Drug: VX-407; Tablets for Oral Administration.
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.	Drug: NGM/EE; Combination Tablets for Oral Administration.; Drug: VX-407; Tablets for Oral Administration.
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.	Drug: NET/EE; Combination Tablets for Oral Administration.; Drug: VX-407; Tablets for Oral Administration.
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.	Drug: DRSP/EE; Combination Tablets for Oral Administration.; Drug: VX-407; Tablets for Oral Administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/EE in the Absence and Presence of VX-407	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	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	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	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	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	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	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	From Day 1 up to Day 7 and Day 21 up to Day 27

Secondary Outcome Measures

Outcome Measure	Time Frame
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 up to Day 36
Part B (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 Up to Day 39
Part C (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 up to Day 32
Part D (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 up to Day 36
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407	Days 9, 15 and 21 up to Day 27
Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407	Days 11, 17 and 23 up to Day 31
Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407	Days 7, 13 and 19 up to Day 23
Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407	Days 9, 15 and 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 VX-407	Days 9, 15 and 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 VX-407	Days 11, 17 and 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 VX-407	Days 7, 13 and 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 VX-407	Days 9, 15 and 21 up to Day 27

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): March 20, 2027

Study Registration Dates

• First Submitted: August 25, 2026
• First Submitted That Met QC Criteria: August 25, 2026
• First Posted (Actual): August 28, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ciliopathies; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Congenital Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Polycystic Kidney Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Polycystic Kidney, Autosomal Dominant
• Other Study ID Numbers: VX26-407-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No