A Bioavailability and Food Effect Study of Venetoclax New Tablet Formulation 2.0 in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events (AE)
研究概览
简要总结
The objective of this study is to assess the bioavailability (BA) of venetoclax new high drug load hot melt extrusion-03 (HME-03) tablet formulation at two different tablet strengths relative to the commercial venetoclax tablet formulation under high-fat conditions in healthy female volunteers. Additionally, this study will assess the potential food effect on the BA of the venetoclax HME-03 tablet at the highest dosage strength.
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
- •Body mass index (BMI) is 18.0 to 32.0 kg/m^
- •Must either be: postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 30 days after the last dose of study drug.
- •Have CD19+ B-cell count > 150 cells/μL at screening.
排除标准
- •History: of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary, or hepatic diseases within the past 6 months that in the option 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 [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
研究组 & 干预措施
Stage 1: Sequence 1: Venetoclax
Participants will receive commercial venetoclax following a high-fat meal (Regimen A), followed by venetoclax hot melt extrusion-03 (HME-03) dose A following a high-fat meal (Regimen B), followed by venetoclax HME-03 dose B following a high-fat meal (Regimen C), finally followed by venetoclax HME-03 dose A following fasting (Regimen D), as part of the approximately 18 month study duration.
干预措施: Venetoclax (Drug)
Stage 1: Sequence 2: Venetoclax
Participants will receive Regimen B, followed by Regimen C, followed by Regimen A, finally followed by Regimen D, as part of the approximately 18 month study duration.
干预措施: Venetoclax (Drug)
Stage 1: Sequence 3: Venetoclax
Participants will receive Regimen C, followed by Regimen A, followed by Regimen B, finally followed by Regimen D, as part of the approximately 18 month study duration.
干预措施: Venetoclax (Drug)
Stage 2: Sequence 1: Venetoclax
Participants will receive Regimen A, followed by Regimen B, finally followed by Regimen C, as part of the approximately 18 month study duration.
干预措施: Venetoclax (Drug)
Stage 2: Sequence 2: Venetoclax
Participants will receive Regimen B, followed by Regimen C, finally followed by Regimen A, as part of the approximately 18 month study duration.
干预措施: Venetoclax (Drug)
Stage 2: Sequence 3: Venetoclax
Participants will receive Regimen C, followed by Regimen A, finally followed by Regimen B, as part of the approximately 18 month study duration.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AE)
时间窗: Up to Approximately 18 Months
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum Observed Plasma Concentration (Cmax) of Venetoclax Hot Melt Extrusion-03 (HME-03)
时间窗: Up to Approximately 18 Months
Cmax of venetoclax HME-03.
Time to Cmax (Tmax) of Venetoclax HME-03
时间窗: Up to Approximately 18 Months
Tmax of venetoclax HME-03.
Apparent Terminal Phase Elimination Constant (β) of Venetoclax HME-03
时间窗: Up to Approximately 18 Months
β of venetoclax HME-03.
Terminal Phase Elimination Half-Life (t1/2) of Venetoclax HME-03
时间窗: Up to Approximately 18 Months
t1/2 of venetoclax HME-03.
Area Under the Plasma Concentration-Time Curve from Time 0 Until the Last Measurable Concentration (AUCt) of Venetoclax HME-03
时间窗: Up to Approximately 18 Months
AUCt of venetoclax HME-03.
Area Under the Plasma Concentration-Time Curve from Time 0 Until Infinity (AUCinf) of Venetoclax HME-03
时间窗: Up to Approximately 18 Months
AUCinf of venetoclax HME-03.
次要结局
未报告次要终点