ACTRN12618001646235已完成1 期
An open label, single cohort, randomized, 4-period crossover Phase 1 study to determine the effect of meal timing relative to CRN00808 administration on the safety and pharmacokinetics of CRN00808 in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
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
- Randomised controlled 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
- •Male and female subjects 18 to 70 years of age
- •- BMI 18 to 30 kg/m2
- •- Females must be non-pregnant and non-lactating, and either surgically sterile, post-
- •menopausal, or using effective method(s) of birth control
- •- Willing to provide signed informed consent
排除标准
- •- Prior treatment with CRN00808
- •- Any uncontrolled or active major systemic disease which makes study participation
- •unsafe or could interfere with evaluation of the endpoints of the study.
- •- History or presence of malignancy except adequately treated basal cell and squamous
- •cell carcinomas of the skin within the past 5 years.
- •- Use of any investigational drug within the past 60 days
- •- Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements
- •- Use of any prior medication without approval of the investigator within 14 days prior to admission
- •- Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
- •- History of alcohol or substance abuse in the past 12 months
- •- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study
研究者
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