A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose, Safety, Tolerability, Pharmacokinetics, and Relative Bioavailability Study of CTP-499 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- To assess safety and tolerability of CTP-499
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CTP-499 following single dose administration.
详细描述
This is a double-blind, single ascending dose administration study of four doses of CTP-499. Following dosing safety and tolerability will be assessed. Blood and urine samples will be taken for pharmacokinetics (PK) and bioavailability. Safety assessments will include monitoring of adverse events, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead ECGs, and physical examination findings.
The plasma concentration time data for CTP-499 and its metabolites will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analysis. The primary pharmacokinetics parameters are: Cmax, Tmax, T1/2, AUClast and AUCinf for plasma; relative bioavailability; and Ae and CLr for urine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •healthy volunteers
- •ages 18 to 55 years old
- •nonsmokers
- •BMI of 18 to 30 kg/m2
排除标准
- •Significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders of drug hypersensitivity
- •Systolic Blood pressure < 90 or > 140, diastolic bp > 90
研究组 & 干预措施
Part A
Single ascending dose administration of four doses of CTP-499 as tablets under fasting condition.
8 subjects per dose group will be enrolled with a 3:1 randomization of active drug to placebo.
Dose levels: 600mg -> 1200mg -> 1800mg -> 2400mg
干预措施: CTP-499 (Drug)
Part B
Part B will consist of a single 400 mg dose of an immediate release capsule of CTP-499 administered under fasting conditions. In Part B 6 subjects will be enrolled.
干预措施: CTP-499 (Drug)
结局指标
主要结局
To assess safety and tolerability of CTP-499
时间窗: 5 days
Assessments will include monitoring of adverse events, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12 lead ECGs, and physical examination findings. Safety data will be summarized using descriptive statistics for all subjects who receive at least 1 dose. Adverse events will be summarized by frequency. Abnormal laboratory and physical exam findings will be summarized by dose and treatment.
次要结局
- To assess Pharmacokinetics, Pharmacodynamics and relative bioavailability(2 days)