NCT03486236已完成1 期
A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With VX-661/Ivacaftor in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This study evaluated the safety and pharmacokinetics of multiple ascending doses of VX-440 in combination with tezacaftor/ivacaftor (TEZ/IVA) (triple combination [TC]) administered for 13 days to healthy male and female subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Female subjects of non-childbearing potential only.
- •Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg.
- •Normal pulmonary function measurements, defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) both ≥80% of their predicted value at screening.
排除标准
- •For female subjects: Pregnant or nursing subjects.
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- •History of hemolysis.
- •Total bilirubin level >2 × ULN at Screening.
- •Other protocol defined Inclusion/Exclusion criteria applied.
研究组 & 干预措施
Cohort C2
Experimental
干预措施: TEZ (Drug)
Cohort C1
Experimental
干预措施: VX-440 (Drug)
Cohort C1
Experimental
干预措施: TEZ (Drug)
Cohort C1
Experimental
干预措施: IVA (Drug)
Cohort C1: Triple Placebo
Placebo Comparator
干预措施: Matched Placebos (Drug)
Cohort C2
Experimental
干预措施: VX-440 (Drug)
Cohort C2
Experimental
干预措施: IVA (Drug)
Cohort C2: Triple Placebo
Placebo Comparator
干预措施: Matched Placebos (Drug)
结局指标
主要结局
Safety and tolerability were based on the number and assessment of adverse events (AEs) and serious adverse events (SAEs)
时间窗: from baseline through safety follow-up visit (up to 29 days)
次要结局
- Maximum observed concentration (Cmax) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)(from Day 1 through Day 18)
- Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)(from Day 1 through Day 18)
- Observed pre-dose concentration (Ctrough) of VX-440, TEZ and its metabolites (M1-TEZ and M2-TEZ), and IVA and its metabolites (M1-IVA and M6-IVA)(from Day 1 through Day 18)
研究者
研究点 (1)
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