NCT00422175已完成1 期
A First-in-Human Study for BAF312: A Two Parts, Single Center, Randomized, Double-Blind, Placebo-Controlled Ascending Single Dose Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral BAF312 in Healthy Volunteers
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
- 63
- 试验地点
- 1
- 主要终点
- safety, tolerability, and pharmacokinetic profile
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and effect of oral BAF312 on bodily functions as well as the body's absorption, distribution, metabolism, and excretion of BAF312 in healthy volunteers
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
- •Healthy male and female subjects, 18 to 55 years of age included, and in good health
- •Female subjects must be either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 1 years)
- •Female subjects test are required to have a negative result for a pregnancy test, not be lactating/breast feeding, and must either:
- •Body mass index (BMI) must be within the range of 18 to 30 Kg/m
- •Subjects must weigh at least 50 kg to participate in this study.
- •Able to communicate with the investigator, to understand and comply with the requirements of the study
- •Understand and sign the written informed consent firm
排除标准
- •Subjects who received live vaccine 4 weeks prior to dosing.
- •Use of any prescription drugs four weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two weeks prior to dosing. Acetaminophen is acceptable
- •Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- •Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- •Significant illness within two weeks prior to dosing.
- •A past personal or close family medical history of clinically significant cardiac abnormalities
- •History of Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease) Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis) Known hypersensitivity or severe adverse event to darifenacin or similar drugs Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. Drug or alcohol abuse
- •Additional protocol defined inclusion/exclusion criteria may apply.
结局指标
主要结局
safety, tolerability, and pharmacokinetic profile
Maximum Tolerated Dose
次要结局
- Pulmonary function
- Lymphocyte counts and lymphocyte recovery period
- Cardiac rate and rhythm
研究者
研究点 (1)
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