An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on the Multiple-Dose Pharmacokinetics of Ivacaftor and on the Multiple-Dose Pharmacokinetics of VX-661 Administered in Combination With Ivacaftor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- PK parameters of ivacaftor and metabolites following concomitant dosing with ciprofloxacin relative to ivacaftor administered alone
研究概览
简要总结
To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the pharmacokinetics of VX-661 when administered in combination with ivacaftor
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Willing and able to comply with scheduled visits, treatment plan, study restrictions,laboratory tests, contraception guidelines, and other study procedures
- •Healthy subjects, as defined by no clinically relevant abnormalities identified by a detailed medical history and full physical examination, including blood pressure and heart rate measurement, standard 12-lead ECG, and clinical laboratory tests.
- •Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg
- •Female subjects of childbearing potential must have a negative serum pregnancy test at screening and at the Day -1 Visit.
排除标准
- •History of any illness, clinical condition, or other factor that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- •Inability to swallow capsules, or inadequate venous access.
- •History of febrile illness within 5 days before the first study drug dose
- •A screen positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus 1 or 2 antibodies.
- •For female subjects: Pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol. For male subjects: Subject has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 120 days after the last study drug dose.
- •Any condition possibly affecting drug absorption
- •Abnormal renal function at screening
研究组 & 干预措施
Cohort 1
participants in Cohort 1 will be administered ivacaftor alone followed by ivacaftor with concomitant ciprofloxacin.
干预措施: ivacaftor (Drug)
Cohort 1
participants in Cohort 1 will be administered ivacaftor alone followed by ivacaftor with concomitant ciprofloxacin.
干预措施: ciprofloxacin (Drug)
Cohort 2
Participants in Cohort 2 will be administered VX-661 in combination with ivacaftor followed by VX-661 in combination with ivacaftor and concomitant ciprofloxacin
干预措施: ivacaftor (Drug)
Cohort 2
Participants in Cohort 2 will be administered VX-661 in combination with ivacaftor followed by VX-661 in combination with ivacaftor and concomitant ciprofloxacin
干预措施: VX-661 (Drug)
Cohort 2
Participants in Cohort 2 will be administered VX-661 in combination with ivacaftor followed by VX-661 in combination with ivacaftor and concomitant ciprofloxacin
干预措施: ciprofloxacin (Drug)
结局指标
主要结局
PK parameters of ivacaftor and metabolites following concomitant dosing with ciprofloxacin relative to ivacaftor administered alone
时间窗: Day 7, Day 14
PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),
PK parameters of VX-661 and metabolites when dosed in combination with ivacaftor and concomitant ciprofloxacin relative to VX-661 administered in combination with ivacaftor
时间窗: Day 10, Day 20
PK parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),
次要结局
- PK parameters of ivacaftor and metabolites when administered in combination with VX-661, with and without concomitant ciprofloxacin(Day 10, Day 20)
- Safety and tolerability, as assessed by adverse events (AEs), vital signs, ECGs and laboratory assessments(Day 1 through Day 21 (cohort 1) or Day 34 (cohort2))