Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: DRSP/EE; Drug: NGM/EE; Drug: Suzetrigine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06820307

VX24-548-019

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of SUZ on the pharmacokinetics of oral contraceptives.

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: 50 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Body mass index of 18.0 to 30.0 kilogram per meter square (Kg/m^2)
• A total body weight greater than (>) 50 kilogram (kg)
• Nonsmoker or ex-smoker for at least 12 months before screening

Key Exclusion Criteria:

• History of febrile or acute illness that has not fully resolved by 14 days before the first dose of study drug
• Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
• 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. This may include, but is not limited to, intolerance to hormonal contraceptives; hypertension; history of deep vein thrombosis; coronary artery disease; cardiovascular disease; systemic lupus erythematosus; migraine; history of breast or cervical cancer; cirrhosis; and history of liver cancer.

Other protocol defined Inclusion/Exclusion criteria will apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE)

Experimental group

Description:

Participants will receive a single dose of DRSP/EE on Days 1 and 20. Participants will also receive SUZ every 12 hours (q12h) from Days 7 through 25.

Treatment:

Drug: Suzetrigine

Drug: DRSP/EE

Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE)

Experimental group

Description:

Participants will receive a single dose NGM/EE on Days 1 and 22. Participants will also receive SUZ every 12 hours (q12h) from Days 9 through 29.

Treatment:

Drug: Suzetrigine

Drug: NGM/EE