A Phase 1, Open-label Drug-drug Interaction Study to Evaluate the Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of SUZ and its Metabolite in the Absence and Presence of Efavirenz
研究概览
简要总结
The purpose of the study is to evaluate the pharmacokinetics (PK) of Suzetrigine (SUZ) and its metabolite in the absence and presence of efavirenz, a moderate CYP3A inducer. In addition, the purpose is to evaluate the safety and tolerability of SUZ when administered in the absence and presence of efavirenz.
详细描述
The study is being conducted to evaluate the effects of efavirenz on the PK of SUZ in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. Participants will receive study medication for a duration of 30 days.
Note: 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
- •A total body weight of greater than (>) 50 kg
- •Males and females of non-childbearing potential
排除标准
- •History of any illness or any clinical condition that may confound the results of the study or pose an additional risk in administering study drug to the participant
- •History of febrile illness or other acute illness that has not fully resolved within 5 days before the first dose of study drug
- •Any condition possibly affecting drug absorption
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
SUZ and Efavirenz
Participants will receive a single dose of SUZ on Days 1 through 15. Participants will also receive a single dose of SUZ in the morning followed by a single dose of efavirenz in the evening on Days 16 through 30.
干预措施: Efavirenz (Drug)
SUZ and Efavirenz
Participants will receive a single dose of SUZ on Days 1 through 15. Participants will also receive a single dose of SUZ in the morning followed by a single dose of efavirenz in the evening on Days 16 through 30.
干预措施: Suzetrigine (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of SUZ and its Metabolite in the Absence and Presence of Efavirenz
时间窗: Day 15 and Day 30
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCτ) of SUZ and its Metabolite in the Absence and Presence of Efavirenz
时间窗: Day 15 and Day 30
次要结局
- Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 46)