A PHASE 1, OPEN-LABEL, SINGLE-DOSE, RANDOMIZED, 2-PERIOD, 2-TREATMENT SEQUENCE CROSS-OVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF COBIMETINIB ADMINISTERED AS A TABLET FORMULATION COMPARED TO A CAPSULE FORMULATION IN HEALTHY SUBJECTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Apparent terminal elimination rate constant
研究概览
简要总结
This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose of the tablet formulation relative to a single dose of the capsule formulation to healthy male and female participants. A minimum of 24 participants (12 participants per sequence) will complete the study. Participants will be randomly assigned to 2 possible sequences (i.e., I: A/B, II: B/A) where the treatments are as follows: Treatment A: One cobimetinib tablet administered as a single oral dose after at least an 8-hour fast; Treatment B: Four cobimetinib capsules administered as a single oral dose after at least an 8-hour fast. The study is expected to last approximately 7 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Healthy male and female volunteers between 18 and 55 years of age, inclusive
- •Body mass index between 18.5 to 32.0 kg/m2, inclusive;
- •Adequate renal, liver, and hematologic function
- •Participants who are in good health as determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator)
研究组 & 干预措施
Capsule formulation
干预措施: cobimetinib (Drug)
Tablet formulation
干预措施: cobimetinib (Drug)
结局指标
主要结局
Apparent terminal elimination rate constant
时间窗: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Half-life (t1/2)
时间窗: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Apparent clearance (CL/F)
时间窗: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Maximum observed concentration (Cmax)
时间窗: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Time to maximum concentration (tmax)
时间窗: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Area under the concentration-time curve (AUC)
时间窗: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Apparent volume of distribution (Vz/F)
时间窗: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
Relative bioavailability (Frel)
时间窗: Days 1 to 10 and 15 to 25 (1 to 10 of the second crossover sequence)
次要结局
- Incidence of adverse events(Up to 4 weeks)