Clinical trial NCT06820307: Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants
Official title: A Phase 1, Open-label Study to Evaluate the Effect of Suzetrigine on the Pharmacokinetics of Oral Contraceptives in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.).

Eligibility 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.

Primary outcomes:
measure: Part A: Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of SUZ
timeFrame: Pre-dose up to Day 25 Post-dose
measure: 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
timeFrame: Pre-dose up to Day 25 Post-dose
measure: 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
timeFrame: Pre-dose up to Day 25 Post-dose
measure: Part B: Maximum Observed Plasma Concentration (Cmax) of NGM Metabolites and EE in the Absence and Presence of SUZ
timeFrame: Pre-dose up to Day 29 Post-dose
measure: 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
timeFrame: Pre-dose up to Day 29 Post-dose
measure: 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
timeFrame: Pre-dose up to Day 29 Post-dose
Secondary outcomes:
measure: Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 40
measure: Part B: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 44
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion - Tempe
state: Arizona
Study officials:
References: