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

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Treatments: Drug: DRSP/EE; Drug: NGM/EE; Drug: NET/EE; Drug: VX-407; Drug: LNG/EE

Study type: Interventional

Funder types: Industry

Identifiers

NCT07074327

VX24-407-006

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 148 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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148 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: LNG/EE

Drug: VX-407

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

Experimental group

Description:

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.

Treatment:

Drug: VX-407

Drug: NGM/EE

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

Experimental group

Description:

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.

Treatment:

Drug: VX-407

Drug: NET/EE

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

Experimental group

Description:

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.

Treatment:

Drug: VX-407

Drug: DRSP/EE