ISRCTN07951717已完成1 期
A phase I, three part study, in healthy subjects to assess the safety, tolerability and pharmacokinetics of single and multiple doses of DSP-2230, and the effect of the administration in the fed and fasted states on the pharmacokinetics of DSP-2230.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females of non-childbearing potential [Parts 1 and 2]
- •2. Females of childbearing potential [Part 3]
- •3. In good health
- •4. Aged 18 to 55 years
- •5. No evidence of systemic disease
- •6. Able to comply with all aspects of the protocol
- •7. Able to give written informed consent to participate in the study
排除标准
- •1. All subjects will not have, or have had a history of, clinically significant neurological, gastrointestinal, renal, hepatic, caridovascular, psychological, metabolic, endocrine, haematological or other major disorders
- •2. They will not have, or have had a history of, drug or alcohol abuse
- •3. They will not have participated in a clinical study with an investigational medicinal product (IMP) within 3 months of randomisation into the current study
- •4. They will not have donated or lost >500mL of blood or blood products in the 3 months preceding the start of dosing
研究者
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