A Phase 1, Randomised, Placebo-Controlled, Ascending Single and Multiple Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of PAT-1251 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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
- •body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
- •body weight of 50 to 100 kg, inclusive
- •subjects must be in good health
排除标准
- •male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception
- •female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception
- •history of, any clinically significant major disorder
- •clinically significant allergic condition
- •significant history of alcoholism or drug/chemical abuse
- •use of any tobacco or nicotine-containing products
- •clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings
- •positive urine drugs of abuse screen or alcohol breath test
研究组 & 干预措施
PAT-1251 Single Dose
Oral solution of PAT-1251, 150 - 4000 mg administered once
干预措施: PAT-1251 (Drug)
Placebo Single Dose
Matching placebo solution administered once
干预措施: Placebo (Drug)
PAT-1251 Multiple Dose
Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days
干预措施: PAT-1251 (Drug)
Placebo Multiple Dose
Matching placebo tablets administered daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: one to seven days
Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination
次要结局
- Maximum Observed Plasma Concentration (Cmax)(one to seven days)
- Area Under the Plasma Concentration Versus Time Curve (AUC)(one to seven days)
- Time to Maximum Observed Plasma Concentration (Tmax)(one to seven days)
- Terminal elimination half-life (t½)(one to seven days)