A Bioavailability and Food Effect Study of Venetoclax New High Drug Load Tablet Formulation in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Venetoclax
研究概览
简要总结
The purpose of this study is to assess the bioavailability of two different doses of venetoclax new high drug load formulation tablets relative to two tablets of the currently marketed venetoclax tablets under fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal.
- •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).
- •Participant must 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.
排除标准
- •History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
研究组 & 干预措施
Regimen A
Participants will receive venetoclax dose A commercial formulation following a high-fat meal.
干预措施: Venetoclax (Drug)
Regimen B
Participants will receive venetoclax dose B new formulation following a high-fat meal.
干预措施: Venetoclax (Drug)
Regimen C
Participants will receive venetoclax dose A new formulation following a high-fat meal.
干预措施: Venetoclax (Drug)
Regimen D
Participants will receive venetoclax dose B new formulation under fasted conditions.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Venetoclax
时间窗: Up to Day 27
Cmax of Venetoclax will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax
时间窗: Up to Day 27
Apparent terminal phase elimination rate constant (β, BETA) of Venetoclax will be assessed.
Time to Cmax (Tmax) of Venetoclax
时间窗: Up to Day 27
Tmax of Venetoclax will be assessed.
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUCt) of Venetoclax
时间窗: Up to Day 27
AUCt of Venetoclax will be assessed.
AUC from Time 0 to Infinity (AUCinf) of Venetoclax
时间窗: Up to Day 27
AUCinf of Venetoclax will be assessed.
Terminal Phase Elimination Half-life (t1/2) of Venetoclax
时间窗: Up to Day 27
Terminal phase elimination half-life (t1/2) of Venetoclax will be assessed.
Number of Adverse Events (AEs)
时间窗: Baseline to Day 57
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
未报告次要终点