Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants
- Registration Number
- NCT06820307
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the effect of SUZ on the pharmacokinetics of oral contraceptives.
- Detailed 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.).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE) NGM/EE 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. Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE) DRSP/EE 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. Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE) Suzetrigine 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. Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE) Suzetrigine 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.
- Primary Outcome Measures
Name Time Method 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Suzetrigine's modulation of oral contraceptive pharmacokinetics in healthy females?
How does Suzetrigine compare to standard-of-care anticonvulsants in altering ethinyl estradiol and gestagen metabolism profiles?
Which biomarkers (e.g., CYP2C9, CYP3A4 variants) predict Suzetrigine-induced changes in oral contraceptive drug interactions?
What are the potential adverse events of Suzetrigine co-administration with combined oral contraceptives in Phase 1 trials?
How does Vertex Pharmaceuticals' Suzetrigine compare to other sodium channel modulators in oral contraceptive drug interaction studies?
Trial Locations
- Locations (1)
Celerion - Tempe
🇺🇸Tempe, Arizona, United States