A Phase I, Open-label, Randomised, 3-way Crossover Study to Characterise and Compare the Pharmacokinetics, Safety and Tolerability of RDC5 Given as a Single Dose to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time 0 to infinity (AUC0-inf) for the whole blood concentration of RDC5
研究概览
简要总结
The purpose of this study is to characterise the pharmacokinetics, safety and tolerability of RDC5 given as a single dose to healthy volunteers at a number of different dose levels
详细描述
This is an open-label, randomised, single dose, 3-way crossover study to characterise and compare the PK, safety and tolerability of RDC5 in 15 healthy male volunteers. Eligible subjects will undergo 3 Treatment Periods, each separated by a washout period at least 14 days. Subjects will receive a single dose of RDC5 during each of the three Treatment Periods in line with their randomized treatment sequence. A total of 4 dose levels will be evaluated within the study, though each subject will only receive 3 doses. A Data Review Team (DRT) will review the pharmacokinetic (PK) data from Treatment Periods 1 and 2 and select the doses to be evaluated in Treatment Periods 2 and 3. Subjects will return for a follow visit 21 days after the last dose of RDC5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Willing to use effective method of contraception
- •Non smoker or ex-smoker within the previous 6 months
排除标准
- •History or presence of any clinically significant findings upon screening
- •Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days
- •Positive result for human immunodeficiency virus (HIV) and/or hepatitis B or C test
- •Positive result for urine alcohol and drug screen
- •Blood donation ≥ 450 mL in the previous 12 weeks
- •Receipt of prescription medicines and/or St John's Wort in the previous 2 weeks
研究组 & 干预措施
RDC5 dose level 2
Single dose of RDC5
干预措施: RDC5 (Drug)
RDC5 dose level 3
Single dose of RDC5
干预措施: RDC5 (Drug)
RDC5 dose level 1
Single dose of RDC5
干预措施: RDC5 (Drug)
RDC5 dose level 4
Single dose of RDC5
干预措施: RDC5 (Drug)
结局指标
主要结局
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) for the whole blood concentration of RDC5
时间窗: Up to 6 days post dose
次要结局
- AUC from time 0 to time of last observed concentration (AUC0-t)(Up to 6 days post dose)
- Maximum observed concentration (Cmax)(Up to 6 days post dose)
- Time at which Cmax occurred (tmax)(Up to 6 days post dose)
- Elimination half-life (t1/2)(Up to 6 days post dose)
- Terminal phase elimination rate constant (λz)(Up to 6 days post dose)
- Apparent volume of distribution (Vd/F)(Up to 6 days post dose)
- Apparent oral clearance (CL/F)(Up to 6 days post dose)
- Number (%) healthy volunteers with treatment emergent adverse events (AEs)(10 weeks)