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

NCT06820307 | Completed Phase 1 FDA Drug

• 1 other identifier: VX24-548-019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (6)

• Part A: Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of SUZ

  Pre-dose up to Day 25 Post-dose

• Part A: 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 SUZ

  Pre-dose up to Day 25 Post-dose

• Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of DRSP and EE in the Absence and Presence of SUZ

  Pre-dose up to Day 25 Post-dose

• Part B: Maximum Observed Plasma Concentration (Cmax) of NGM Metabolites and EE in the Absence and Presence of SUZ

  Pre-dose up to Day 29 Post-dose

• Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of NGM Metabolites and EE in the Absence and Presence of SUZ

  Pre-dose up to Day 29 Post-dose

• Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of NGM Metabolites and EE in the Absence and Presence of SUZ

  Pre-dose up to Day 29 Post-dose

Secondary Outcomes (2)

• 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 40

• Part B: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 1 up to Day 44

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Suzetrigine; Drug: DRSP/EE

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

EXPERIMENTAL

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.

Drug: Suzetrigine; Drug: NGM/EE

Interventions

Suzetrigine DRUG

Tablets for Oral Administration.

Also known as: VX-548, SUZ

Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE); Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE)

DRSP/EE DRUG

Combination Tablets for Oral Administration.

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

NGM/EE DRUG

Combination Tablets for Oral Administration.

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

Celerion - Tempe

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: February 25, 2025
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)