NCT00789126已完成1 期
A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study and Multiple-Dose Escalation Study of VX-509 in Healthy Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables
研究概览
简要总结
Study to evaluate the safety and tolerability of single ascending doses and multiple ascending doses of VX-509 administered to healthy male and female subjects
详细描述
Part A of the study will evaluate the safety and tolerability, PK, and PD of single ascending doses of VX-509.
Part B will evaluate the safety and tolerability, PK, and PD of multiple ascending doses of VX-509 administered for 14 days.
A total of 72 subjects will be enrolled: 36 subjects in Part A and 36 subjects in Part B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking male or healthy, non-smoking, non-pregnant female
- •Able to comply with study procedures
- •Male subjects must agree to use 2 highly effective methods of contraception
- •Female subjects must be of documented non-child-bearing potential or must agree to use 2 highly effective methods of contraception
- •No clinically significant abnormal results for physical examination or clinically significant out of range laboratory results
排除标准
- •History of any significant illness
- •Illness within 5 days before Day 1
- •Regular treatment with any medications
- •Any type of tobacco or nicotine use
- •History of drug or alcohol abuse or addiction within 2 years before Screening visit
- •Positive tuberculin skin test at Screening
- •Female subjects who are lactating or planning to become pregnant during the study period or within 90 days of last dose of study drug
结局指标
主要结局
Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables
时间窗: Specified timepoints in the protocol
次要结局
- Pharmacokinetics (PK) parameters (Cmax, AUC, t1/2, tmax)(Specified timepoints in the protocol)
- Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers(Specified timepoints in the protocol)
研究者
研究点 (1)
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