ACTRN12613000545763已完成1 期
Open-label study to assess the pharmacokinetics, safety and tolerability of siponimod in healthy subjects with CYP2C9 extensive (EM) and poor metabolizer (PM) phenotype.
ovartis Pharmaceuticals Australia Pty Limited0 个研究点目标入组 24 人开始时间: 2013年5月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1) Healthy male and female subjects aged 18 to 70 years, inclusive.
- •2) Female subjects must be of non-child bearing potential.
- •3) Body weight: greater than or equal to 50.0 kg; BMI: 18.0-30.0 kg/m2, inclusive.
排除标准
- •1) Subjects with CYP2C9 *1/*2, *2/*2, and *1/*3 genotypes according to screening results.
- •2) Clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases which has not resolved within two weeks prior to initial dosing.
- •3) History or presence (=screening or first baseline) of any clinically significant ECG abnormalities.
- •4) Any clinically significant laboratory abnormalities at screening that may jeopardize the subjects' safety throughout the study (as judged by the investigator).
- •5) Smokers as defined by reported tobacco use or urine cotinine concentrations greater than or equal to 500 ng/mL at screening or baseline visit.
- •6) Use of any prescription drug, herbal drug or over-the-counter medication from four weeks prior to initial dosing.
- •7) Pregnant or nursing (lactating) females.
- •8) Any surgical or medical condition which, as judged by the investigator, might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
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