A Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Safety and Pharmacokinetic Study of Ascending Doses of CB-183,315 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Number of participants with an Adverse Event (AE)
研究概览
简要总结
This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males and females.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease or gastroesophageal reflux disease documented on endoscopy
- •Electrocardiogram (ECG) shows no clinically significant abnormalities
- •Is able to swallow capsules
- •is in good health
排除标准
- •Pregnant or lactating females
- •Has had Clostridium (C.) difficile disease within 1 year prior to entry into the study
- •Has received an investigational drug or participated in any experimental procedure within1 month prior to study entry and at least 6 half lives from last intake of study drug
- •Participants 18 to 49 years of age had taken any regular, prescribed, or over-the-counter medication
- •Has any significant concurrent therapies
- •Has a positive drug screen
- •Has a positive human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C screen
- •Has given more than 450 mL of blood (one unit) in the 60 days preceding screening
- •Is an active intravenous drug user or abuses alcohol
- •Has had a malignancy within the last 5 years
- •Has inadequate protection against pregnancy during the conduct of the study and until 1 month after last dose of study drug
- •Has received any antibiotics within 30 days prior to first dose of study drug
- •Has been hospitalized within the past 30 days prior to Study Day 1
- •Has known hypersensitivity to daptomycin
研究组 & 干预措施
Surotomycin 0.5 g
A single oral dose of 0.5 g surotomycin in hard gelatin capsules
干预措施: Surotomycin (Drug)
Surotomycin 1 g
A single oral dose of 1 g surotomycin in hard gelatin capsules
干预措施: Surotomycin (Drug)
Surotomycin 2 g
A single oral dose of 2 g surotomycin in hard gelatin capsules
干预措施: Surotomycin (Drug)
Surotomycin 4 g
A single oral dose of 4 g surotomycin in hard gelatin capsules
干预措施: Surotomycin (Drug)
Placebo
A single oral dose of placebo for surotomycin in hard gelatin capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with an Adverse Event (AE)
时间窗: Up to Day 9
Number of participants who discontinued study due to an AE
时间窗: Up to Day 9
次要结局
未报告次要终点