CG-549 Tablet Pharmacokinetics Study: An Open-label, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of a Tablet Formulation of CG-549 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of CG549
研究概览
简要总结
This will be an open label, crossover, single dose study consisting of 2 parts (Part A and Part B) in a total of 24 healthy male and female subjects.
详细描述
Part A Part A is an open-label, 3-period, fixed-sequence, escalating dose study in 6 healthy subjects to find a tablet dose that results in a CG-549 exposure that is expected to be safe and potentially efficacious (i.e., within the targeted efficacious exposure range as defined below).
Subjects will receive the following treatments of the tablet formulation of CG-549, in the fed state:
- Period 1: a single oral dose of 300 mg CG-549 on Day 1.
- Period 2: a single oral dose of XX mg CG-549 on Day 1. After interim PK evaluation of Period 1, the CG-549 dose of Period 2 will aim at reaching the lower end of the targeted efficacious exposure range.
- Period 3: a single oral dose of YY mg CG-549 on Day 1. After interim PK evaluation of Period 2, the CG-549 tablet dose of Period 3 will aim at reaching the higher end of the targeted efficacious exposure range.
Doses XX and YY will be multiples of 300 mg and will not exceed 3 times the dose used in the preceding period.
After interim PK evaluation of all periods in Part A, the CG-549 dose and the type of breakfast to be used in Part B will be selected which is anticipated to result in an exposure that is expected to be safe and potentially efficacious.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Sex:Males and females
- •Age:18 to 55 years, inclusive, at screening
- •Weight:≥50 kg, at screening
- •Body mass index:18.0 to 30.0 kg/m2, inclusive, at screening
- •Smoking behavior :Non-smoking or smoking ≤5 cigarettes, 1 cigar, or 1 pipe per day
- •Other criteria:Liver enzymes within the normal range and creatine phosphokinase within 2.0 times the normal range
排除标准
- •Previous participation in the current study.
- •Employee of PRA or the Sponsor.
- •History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month prior to screening.
- •Presence or history of esophageal or gastroduodenal ulceration within 1 month prior to screening.
- •Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, in the opinion of the Investigator.
研究组 & 干预措施
fed state in PART B
干预措施: CG-549 (Drug)
fasted state in PART B
干预措施: CG-549 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of CG549
时间窗: up to 4 weeks
Area Under the Concentration-Time Curve (AUC) of CG549
时间窗: up to 4 weeks
次要结局
- The Number of Participants Who Experienced Serious or Non-Serious Adverse Events(up to 4 weeks)