A Phase 1, Open-Label Study to Evaluate the Effect of Crushing and Grinding on the Bioavailability of Venetoclax Tablet in Healthy Adult Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Adverse Events
研究概览
简要总结
The objective of this study is to assess the oral bioavailability of crushed and ground venetoclax commercial tablets relative to the intact venetoclax commercial tablets under fed condition in healthy female participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must either be: postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 1 month after the last dose of study drug.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
排除标准
- •Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect her participating in this study.
- •History of any clinically significant sensitivity or allergy to any medication or food.
- •History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption.
研究组 & 干预措施
Venetoclax Sequence 1
Participants will receive whole venetoclax, followed by crushed venetoclax, and completed with ground venetoclax for a 15 day period.
干预措施: Venetoclax (Drug)
Venetoclax Sequence 2
Participants will receive crushed venetoclax, followed by ground venetoclax, and completed with whole venetoclax for a 15 day period.
干预措施: Venetoclax (Drug)
Venetoclax Sequence 3
Participants will receive ground venetoclax, followed by whole venetoclax, and completed with crushed venetoclax for a 15 day period.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: Up to 75 Days
An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Venetoclax
时间窗: Up to 45 Days
AUCt of venetoclax.
Apparent Terminal Phase Elimination Rate Constant (β) of Venetoclax
时间窗: Up to 45 Days
Apparent terminal phase elimination rate constant of venetoclax.
Maximum Observed Plasma Concentration (Cmax) of Venetoclax
时间窗: Up to 45 Days
Cmax of venetoclax.
Time to Cmax (Tmax) of Venetoclax
时间窗: Up to 45 Days
Tmax of venetoclax.
AUC From Time 0 to the Time Infinity (AUCinf) of Venetoclax
时间窗: Up to 45 Days
AUCinf of venetoclax.
Terminal Phase Elimination Half-life (t1/2) of Venetoclax
时间窗: Up to 45 Days
T1/2 of venetoclax.
次要结局
未报告次要终点