An Open-label, Single Dose, Three Sequence Study in Healthy Adult Volunteers to Evaluate the Pharmacokinetics, Safety and Tolerability of RV521 Administered as the Drug in Capsule Formulation in the Fed State and the Dry Powder Blend Formulation Dispersed in Water in the Fed and Fasted States
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Terminal half life (t1/2) for RV521
研究概览
简要总结
The main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to comply with protocol defined contraception requirements
- •In good health with no history of major medical conditions
- •A body mass index (BMI) of 18-25 kg/m^2, inclusive
排除标准
- •Evidence of any clinically significant or currently active major medical condition
- •Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
- •Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products
研究组 & 干预措施
RV521
Three single 200 mg oral doses of RV521 administered on Day 1, Day 5 and Day 9 as either the drug in capsule (1 dosing occasion) or the dry powder blend dispersed in water (2 dosing occasions)
干预措施: RV521 (Drug)
结局指标
主要结局
Terminal half life (t1/2) for RV521
时间窗: Baseline to study day 11
Maximum observed plasma concentration (Cmax) for RV521
时间窗: Baseline to study day 11
Time to maximum plasma concentration (tmax) for RV521
时间窗: Baseline to study day 11
Area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t) for RV521
时间窗: Baseline to study day 11
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for RV521
时间窗: Baseline to study day 11
次要结局
- Incidence of treatment emergent adverse events as assessed by CTCAE V5.0(Screening to final study visit (performed at 7 days following the last dose of any intervention))
- Proportion of subjects with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation and urinalysis)(Screening to final study visit (performed at 7 days following the last dose of any intervention))
- Proportion of subjects with morphological and/or rhythm abnormalities on ECG(Screening to final study visit (performed at 7 days following the last dose of any intervention))
- Proportion of subjects with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals)(Screening to final study visit (performed at 7 days following the last dose of any intervention))
- Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure and pulse rate)(Screening to final study visit (performed at 7 days following the last dose of any intervention))