A Randomized, Open-label, Phase I Study to Assess the Effects of Food and Formulation on the Pharmacokinetics of a Single Dose of Rilzabrutinib (SAR444671 [Formerly PRN1008]) in Healthy Male and Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax
研究概览
简要总结
Primary Objective:
- To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects.
- To evaluate the impact of formulation on the PK of rilzabrutinib following single oral doses to healthy subjects
Secondary Objective:
- To assess the safety and tolerability of single oral doses of rilzabrutinib administered under fasted and fed conditions
详细描述
The total study duration is approximately 43 days for each participant, including a screening period of 2 to 28 days, treatment period of 12 days, and follow-up of 3 days
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
- 18 Years 至 65 Years（Adult, Older 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
Group 1
Participants will receive caplets after fast (treatment A) on Day 1 and caplets after meal (treatment B) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11.
干预措施: rilzabrutinib SAR444671 (Drug)
Group 2
Participants will receive caplets after meal (treatment B) on Day 1 and caplets after fast (treatment A) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11.
干预措施: rilzabrutinib SAR444671 (Drug)
结局指标
主要结局
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax
时间窗: From Day 1 to Day 7
time to maximum plasma concentration
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-inf
时间窗: From Day 1 to Day 7
area under the plasma concentration-time curve from zero to infinity
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-last
时间窗: From Day 1 to Day 7
area under the plasma concentration-time curve from zero to the last measurable concentration
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax
时间窗: From Day 1 to Day 7
maximun plasma concentration
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-last
时间窗: From Day 11 to Day 12
area under the plasma concentration-time curve from zero to the last measurable concentration
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: half-life
时间窗: From Day 1 to Day 7
terminal elimination phase half-life
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Cmax
时间窗: From Day 11 to Day 12
maximun plasma concentration
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: half-life
时间窗: From Day 11 to Day 12
terminal elimination phase half-life
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Tmax
时间窗: From Day 11 to Day 12
time to maximum plasma concentration
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-inf
时间窗: From Day 11 to Day 12
area under the plasma concentration-time curve from zero to infinity
次要结局
- Treatment-emergent AE and treatment-emergent SAE(Until Day 15)