A Two-Part Study Investigating The Relative Bioavailability And The Potential Food Effect After A Single Oral Dose Administration Of A New Formulation of SYT-510, And The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Oral Dose Administration Of SYT-510 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Part 1: Maximum Observed Concentration (Cmax) of SYT-510
研究概览
简要总结
Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510. Part 1 will then guide dosing in Part 2, a multiple dose study which aims to assess safety, tolerability and pharmacokinetic of multiple SYT-510 administrations.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females of non-childbearing potential (WOCBP) aged 18 to 65 years old (inclusive) at the date of signing the informed consent form (ICF).
- •Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
- •Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at Screening and Admission (e.g Day -1 or Day -2) and a minimum weight of 50kg.
排除标准
- •Current or recurrent disease that as judged by the Investigator may interfere with the execution of the conduct of the study.
- •Laboratory parameters outside of the laboratory normal range.
- •Positive test results for alcohol or drugs of abuse.
- •Treatment with an investigational drug within 90 days preceding the first dose of trial medication.
- •Known or suspected intolerance or hypersensitivity to the investigational product, any closely related compound, or any of the stated ingredients.
- •History of significant allergic reactions (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc).
- •Current smokers and those who have smoked within the last 6 months.
研究组 & 干预措施
Part 1: Relative bioavailability and food effect
Randomised, open label, single-dose, three period, three-sequence crossover study to evaluate the relative bioavailability (rBA) of a new oral formulation of SYT-510 under fasting conditions and the effect of food in healthy participants.
干预措施: SYT-510 (Drug)
Part 2: Multiple Ascending Dose
Randomised, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants to assess the safety, tolerability and pharmacokinetics (PK) of SYT-510 after repeated administrations.
干预措施: SYT-510 (Drug)
Part 2: Multiple Ascending Dose
Randomised, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants to assess the safety, tolerability and pharmacokinetics (PK) of SYT-510 after repeated administrations.
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1: Maximum Observed Concentration (Cmax) of SYT-510
时间窗: Up to 72 hours post-dose
Part 1: Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SYT-510
时间窗: Up to 72 hours post-dose
Part 1: AUC of SYT-510
时间窗: Up to several days post last dose
Part 2: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of multiple ascending doses of SYT-510
时间窗: Up to Day 20
次要结局
- Part 1: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of single doses of SYT-510(Up to Day 4)
- Part 2: Maximum observed concentration (Cmax) of SYT-510(Up to Day 14)
- Part 2: Time of maximal plasma concentration (tmax) of SYT-510(Up to Day 14)
- Part 2: AUCtau of SYT-510(Up to Day 14)
- Part 2: Terminal elimination half-life (t1/2) of SYT-510(Up to several days post last dose)
- Part 2: Accumulation ratio of SYT-510(Up to Day 14)