A Phase 1, Open-label Study to Evaluate the Effect of Suzetrigine on the Pharmacokinetics of Oral Contraceptives in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
The purpose of this study is to evaluate the effect of SUZ on the pharmacokinetics of oral contraceptives.
详细描述
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.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Part A: SUZ with Drospirenone/Ethinyl Estradiol (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.
干预措施: Suzetrigine (Drug)
Part A: SUZ with Drospirenone/Ethinyl Estradiol (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.
干预措施: DRSP/EE (Drug)
Part B: SUZ with Norgestimate/Ethinyl Estradiol (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.
干预措施: Suzetrigine (Drug)
Part B: SUZ with Norgestimate/Ethinyl Estradiol (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.
干预措施: NGM/EE (Drug)
结局指标
主要结局
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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Pre-dose up to Day 25 Post-dose
次要结局
- 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)