KCT0000363暂停未知
A single center, randomized, double-blind, placebo-controlled, single and multiple-dose study of DEB025 (alisporivir) in healthy Chinese and Caucasian subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 50(Year)（—）
- 性别
- All
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •- Healthy male and female subjects (Chinese and Caucasian) age 18 to 50 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •- Women without child bearing potential/post-menopausal women
- •- must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 28 kg/m2.
- •- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
排除标准
- •- A history of clinically relevant cardiac rhythm disorders
- •- Any of the following ECG abnormalities at Screening or Baseline prior to period 1 dosing:
- •PR > 220 msec
- •QRS complex > 120 msec
- •Long QT syndrome
- •QTcF > 430 msec (males)
- •QTcF > 450 msec (females)
- •- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •- Pregnant or nursing (lactating) women
- •- Fertile males, defined as all males physiologically capable of conceiving offspring UNLESS sexually active males must use a condom during intercourse while taking the drug and for 3 weeks after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via seminal fluid.
- •- Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
- •Plasma donation (> 400 ml) within 7 days prior to first dosing.
- •- Hemoglobin levels below 12.0 g/dl at screening or first baseline.
- •- Platelet count below the lower limit of the laboratory reference range at screening
- •- Significant illness within two (2) weeks prior to initial dosing.
- •- History or evidence of any of inherited bilirubin disease or disorder, including but not necessarily limited to Dubin-Johnson Syndrome, Gilbert’s syndrome and Rotor Syndrome.
研究者
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