NCT00409929已完成1 期
A Randomized, Double-blind, Placebo-controlled, Time Lagged, Parallel Group, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AEB071 Doses Greater Than 500 mg in Healthy Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Safety and tolerability of ascending single oral doses of AEB071 in healthy subjects.
研究概览
简要总结
This study will evaluate the safety and tolerability of ascending single oral doses greater than 500 mg of AEB071 in healthy 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
- Double
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
- •Male and/or female subjects from 18-55 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening.
- •Female subjects had to either have been surgically sterilized or be postmenopausal.
排除标准
- •Use of any prescription drug or over-the-counter medication within 2 weeks prior to dosing, or 2 months for inducers or inhibitors of cytochrome CYP4503A4 (paracetamol acceptable)
- •Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing
- •A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
- •History of History of fainting, hypotension when standing up, arrhythmia, acute or chronic bronchospastic disease
- •History of clinically significant drug allergy; atopic allergy or a known hypersensitivity to any of the study drugs or drugs similar to the study drugs
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study
- •History of immunocompromise (including a positive HIV test result) or drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse or a current positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •Additional protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Safety and tolerability of ascending single oral doses of AEB071 in healthy subjects.
Maximum Tolerated Dose
次要结局
- Measure inhibition of lymphocytes activation following rising oral doses of AEB071 in healthy subjects after each single dose
- Conduct exploratory genomic studies to identify gene expression patterns of blood cells at the end of study
- Assess the pharmacokinetics of single oral doses of AEB071 at the end of study
- Measure the pharmacokinetic/pharmacodynamic relationship of single rising oral doses of AEB071 in healthy subjects after each single dose
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability and Pharmacokinetics Study of LY03005Major Depressive DisorderNCT02055300Luye Pharma Group Ltd.88
已完成
1 期
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy SubjectsInflammatory Bowel DiseaseNCT01221818Eisai Inc.48
已完成
1 期
Investigation Of a New Oral Anti-Histamine in Healthy Male SubjectsRhinitis, Allergic, SeasonalNCT00605852GlaxoSmithKline29
已完成
1 期
Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in HealthyHealthy SubjectsOsteoarthritisNCT00380900Wyeth is now a wholly owned subsidiary of Pfizer
已完成
1 期
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF10073 After Single and Multiple Doses in Healthy Volunteers and the Effect of Itraconazole on CHF10073 ExposurePulmonary FibrosisNCT06746064Chiesi Farmaceutici S.p.A.155