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

NCT07074327 | Completed Phase 1 FDA Drug

• 1 other identifier: VX24-407-006
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. Also, to evaluate the safety and tolerability of co-administration of VX-407 with LNG/EE, NGM/EE, NET/EE and DRSP/EE.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Keywords

Oral contraceptives; Drug interaction; Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Part A: Maximum Observed Plasma Concentration (Cmax) of LNG 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 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 B (Optional): 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 B (Optional): AUC0-inf of NGMN and 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): 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 C (Optional): 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): 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 D (Optional): 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 Outcomes (12)

• 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 40

• 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: Cmax of VX-407

  Days 9, 15 and 21 up to Day 27

Study Arms (4)

Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE)

EXPERIMENTAL

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: VX-407; Drug: LNG/EE

Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE)

EXPERIMENTAL

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: VX-407; Drug: NGM/EE

Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE)

EXPERIMENTAL

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: VX-407; Drug: NET/EE

Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)

EXPERIMENTAL

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: VX-407; Drug: DRSP/EE

Interventions

DRSP/EE DRUG

Combination Tablets for Oral Administration.

Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)

VX-407 DRUG

Suspension for oral administration.

Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE); Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE); Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE); Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)

LNG/EE DRUG

Combination Tablets for Oral Administration.

Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE)

NGM/EE DRUG

Combination Tablets for Oral Administration.

Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE)

NET/EE DRUG

Combination Tablets for Oral Administration.

Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

Altasciences - Kansas City

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 20, 2025
• Study Start: July 11, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 27, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)