A Single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics Following Single Doses of MIV-711 Capsule and Tablet Formulations 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
- Apparent terminal elimination rate constant (Kel)
研究概览
简要总结
This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MIV-711 ABCD
Subjects will first receive the tablet formulation under fasted conditions (A) followed by the tablet formulation administered under fed conditions (B). Thereafter they will receive the capsule formulation under fasted conditions (C) followed by the capsule formulation administered under fed conditions (D).
干预措施: MIV-711 (Drug)
MIV-711 CDAB
Subjects will first receive the capsule formulation under fasted conditions (C)followed by the capsule formulation administered under fed conditions (D). Thereafter they will receive the tablet formulation under fasted conditions (A) followed by the tablet formulation administered under fed conditions (B).
干预措施: MIV-711 (Drug)
结局指标
主要结局
Apparent terminal elimination rate constant (Kel)
时间窗: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t)
时间窗: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf)
时间窗: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Maximum observed concentration (Cmax)
时间窗: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Time to reach maximum observed concentration (Tmax)
时间窗: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Apparent terminal elimination half-life (T½)
时间窗: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
次要结局
- The number and severity of AEs/SAE(from study start until 7+/-2 days after the last study drug administration)
- The number of clinically significant abnormal lab results(from study start until 7+/-2 days after the last study drug administration)
- The number of clinically significant ECG abnormalities(from study start until 7+/-2 days after the last study drug administration)
- The number of clinically significant physical examination abnormalities(from study start until 7+/-2 days after the last study drug administration)