PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetic assessments of icosabutate - AUC
研究概览
简要总结
PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Objective:
- To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects
- To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males of females
- •any ethnic origin
- •Age 18-55 years
- •BMI 18.0 - 33.0 kg/m2
- •generally in good health
- •signed informed consent
排除标准
- •males or females not willing to use appropriate contraception
- •recent blood donation
- •recent blood received
- •high consumption of alcohol
- •high consumption of tobacco
- •subjects who have engaged in heavy exercise last two weeks
- •prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety
- •other medication know to alter drug absorption or elimination
- •abnormal heart rate or blood pressure or 12-lead ECG
- •significant history of drug allergy, or hypersensitivity to treatment ingredients
- •ocular disorder requiring topical ocular therapy, or recent allergic eye disease
- •other significant medical history or physical findings
研究组 & 干预措施
Icosabutate dose 1
Dose 1
干预措施: icosabutate (Drug)
Icosabutate dose 2
Dose 2
干预措施: icosabutate (Drug)
Icosabutate dose 3
Dose 3
干预措施: icosabutate (Drug)
Placebo
Placebo (medium chain triglycerides)
干预措施: icosabutate (Drug)
Icosabutate dose 4
Dose 4
干预措施: icosabutate (Drug)
结局指标
主要结局
Pharmacokinetic assessments of icosabutate - AUC
时间窗: 0-36 hour
Exposure level of icosabutate measured as Area Under the Curve (AUC)
Pharmacokinetic assessments of icosabutate - Cmax
时间窗: 0-36 hour
Maximum observed plasma concentration of icosabutate (Cmax)
Number of patients with Adverse Events
时间窗: During the 36 hour assessment, and at post-study visit day 5-7
Clinically significant abnormalities found during the course of the study will be followed up until they return to normal or can be clinically explained
次要结局
未报告次要终点