A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF FORMULATION AND TABLET HARDNESS ON THE RELATIVE BIOAVAILABILITY OF PICTILISIB (GDC-0941) IN HEALTHY SUBJECTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Area under the concentration-time curve (AUC) of plasma GDC-0941
研究概览
简要总结
This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the relative bioavailability of GDC-0941 administered as a single dose of the market image formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the Phase 2 formulation to healthy male and female volunteers. Participants will be randomly assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation), and GDC-0941 will be administered based on the assigned sequence. The study is expected to last 8 weeks.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants between 18 and 55 years of age, inclusive,
- •Body mass index (BMI) between 18.5 to 32 kg/m2, inclusive,
- •Healthy, as determined by no clinically significant findings from medical history, ECG, and vital signs, and who are able to swallow and tolerate a tethered Heidelberg pH Capsule and have gastric pH measurements taken
排除标准
- •Any medical condition or history of such condition that may, in the opinion of the investigator, contraindicate participation in this study
研究组 & 干预措施
Crossover sequence 1
干预措施: GDC-0941 (Drug)
Crossover sequence 2
干预措施: GDC-0941 (Drug)
Crossover sequence 3
干预措施: GDC-0941 (Drug)
Crossover sequence 4
干预措施: GDC-0941 (Drug)
结局指标
主要结局
Area under the concentration-time curve (AUC) of plasma GDC-0941
时间窗: 25 Days
Maximum plasma concentration (Cmax) of GDC-0941
时间窗: 25 Days
Relative bioavailability (Frel) according to the model independent approach
时间窗: 25 days
次要结局
- Incidence of adverse events(25 days)
- Electrocardiogram (ECG)(25 days)