NCT01561807已完成2 期
A Phase 2a, Randomized, Double-Blind,Placebo-Controlled Study to Investigate the Effects of VX-787 Administered to Adult Volunteers Experimentally Inoculated With Live Influenza Virus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- The primary endpoint is viral AUC as calculated in cell culture of nasal swabs (quantitation of nasal swabs for viral infectivity by cell culture), from initiation of VX-787 treatment
研究概览
简要总结
The purpose of this study is to determine the antiviral activity and safety of VX-787 given to healthy adult volunteers that have been inoculated with the influenza virus.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Negative human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C(HCV) antibody screen
- •Have not been vaccinated for influenza virus since 2006 or had a known influenza-like illness in the current season (as determined in the medical history), defined as in the last 12 months before Screening
排除标准
- •Subjects who are pregnant or nursing, or who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period (from at least 14 days before the first dose until 90 days of the last dose of study drug)
- •Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness
- •Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry
- •Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral inoculation
- •Intending to travel(to countries for which vaccinations are recommended or where high risk of infections exists)
- •Subjects with a history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any etiology; any history during adulthood of asthma of any etiology, COPD, or any use of a bronchodilator or other asthma medication during adulthood
- •Regular daily smokers
- •History or evidence of autoimmune disease or known impaired immune responsiveness
- •History of heart failure or any other severe cardiac abnormality including clinically significant arrhythmia
- •Receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine, medication, or experimental respiratory viral challenge delivered directly to the respiratory tract within 1 year before viral inoculation
- •Previous exposure to study drug or similar substance(s)
研究组 & 干预措施
787 low dose
Experimental
VX-787 low dose capsule, taken orally for 5 days
干预措施: VX-787 (Drug)
787 high dose
Experimental
VX-787 high dose capsule, taken orally for 5 days
干预措施: VX-787 (Drug)
Placebo low dose
Experimental
Matching placebo low dose capsule, taken orally for 5 days
干预措施: Placebo (Drug)
Placebo high dose
Experimental
Matching placebo high dose capsule, taken orally for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint is viral AUC as calculated in cell culture of nasal swabs (quantitation of nasal swabs for viral infectivity by cell culture), from initiation of VX-787 treatment
时间窗: up to 11 days
次要结局
- Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs.(up to 33 days)
- Total tissue count and total mucus weight after viral inoculation(up to 10 days)
- Sequence analysis of the relevant target region of influenza(up to 8 days)
- Pharmacokinetic (PK) parameters of VX-787(8 days)
- Composite symptom score AUC(up to 8 days)
- Viral AUC calculated by RT-PCR of nasal swabs, from initiation of VX-787 treatment(up to 8 days)
- Duration of viral shedding by cell culture and/or RT-PCR(up to 8 days)
- Peak viral shedding titer by cell culture and/or RT-PCR(up to 8 days)
- Time to resolution from peak viral shedding by cell culture and/or RT-PCR(up to 8 days)
- Time to peak of composite sympton score, duration, and time to resolution of composite score from peak(up to 8 days)
- Peak severity of symptoms after viral inoculation(up to 8 days)
- Duration of influenza-like illness after viral inoculation(up to 8 days)
研究者
相似试验
已完成
2 期
Study of VX-765 in Subjects With Treatment-resistant Partial EpilepsyPartial EpilepsyNCT01048255Vertex Pharmaceuticals Incorporated60
终止
2 期
A Study to Evaluate the Efficacy and Safety of VX-765 in Subjects With Treatment-Resistant Partial EpilepsyEpilepsyNCT01501383Vertex Pharmaceuticals Incorporated55
已完成
2 期
Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702Rheumatoid ArthritisNCT00205478Vertex Pharmaceuticals Incorporated300
已完成
2 期
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a BunionectomyAcute PainNCT04977336Vertex Pharmaceuticals Incorporated274
已完成
2 期
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an AbdominoplastyAcute PainNCT05034952Vertex Pharmaceuticals Incorporated303