An Open Label, Randomized, Single Dose, Cross Over Study to Evaluate Food Effects on Relative Bioavailability of RP6530 Administered in Fasting and Fed Conditions in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))
研究概览
简要总结
This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects. The subjects will receive the study medication under either fed or fast during each treatment period.
详细描述
The present study will be conducted in healthy male volunteers. A single oral dose will be administered to the subject in each treatment period (under either fasting or fed state). Each treatment period will be separated by at least 7 calendar days. Post dose PK blood samples will be collected in each treatment period to evaluate the food effect on bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers; aged 18 to 45 years;
- •Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;
- •Non- smokers or ex-smokers;
- •Able to give informed consent.
排除标准
- •Subjects with evidence or history of clinically significant disease;
- •Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests;
- •Subjects who have received any investigational drug in the previous 28 days;
- •Subjects participated in a study with PI3k inhibitors at least once in past year;
- •Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.
研究组 & 干预措施
RP6530 in fast condition
A single dose of RP6530 following fast condition
干预措施: RP6530 (Drug)
RP6530 in fed condition
A single dose of RP6530 following fed condition
干预措施: RP6530 (Drug)
结局指标
主要结局
Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))
时间窗: up to 24 hours post-dose.
Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.
次要结局
- Number of Participants Who Were Evaluated for Adverse Events(7 days)
- Pharmacokinetic Parameters(up to 24 hours post-dose.)