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

Phase 1CompletedNCT06820307

Vertex Pharmaceuticals Incorporated50 enrolled

Overview

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

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.).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

SuzetrigineDRUG

Tablets for Oral Administration.

DRSP/EEDRUG

Combination Tablets for Oral Administration.

NGM/EEDRUG

Combination Tablets for Oral Administration.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion - Tempe

Tempe, Arizona, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Pre-dose up to Day 29 Post-dose

Secondary Outcomes

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

Time frame: 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)

Data from ClinicalTrials.gov

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