A Phase I, Single Center, Randomized, Open-Label Study Investigating the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics of GDC-0853 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Extrapolated Area Under the Curve (AUC Percent [%] Extrap) of GDC-0853
研究概览
简要总结
The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both. This will be a 3-part open-label randomized study conducted in healthy adult participants. Approximately 63 subjects will be enrolled in this study.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female (of non-childbearing potential) participants
- •Within body mass index range 18.0 to 32.0 kilogram per meter square (kg/m^2), inclusive
- •In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs and physical examinations
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
排除标准
- •History or symptoms of any significant disease
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- •History of stomach or intestinal surgery or resection
- •Participants who previously participated in any other investigational study drug trial within 90 days prior to Check-in. Participants who previously received GDC-0853 in previous studies.
- •History of malignancy
- •Pregnancy, lactation, or breastfeeding in female participants
研究组 & 干预措施
Part 1: GDC-0853 (Effect of Formulation)
Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state.
干预措施: GDC-0853 (Drug)
Part 1: GDC-0853 (Effect of Formulation)
Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state.
干预措施: Rabeprazole (Drug)
Part 2: GDC-0853 (Effect of Food and Rabeprazole)
Participants will receive three single oral doses of one GDC-0853 formulations selected from Part 1 of this study. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.
干预措施: GDC-0853 (Drug)
Part 2: GDC-0853 (Effect of Food and Rabeprazole)
Participants will receive three single oral doses of one GDC-0853 formulations selected from Part 1 of this study. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.
干预措施: Rabeprazole (Drug)
Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)
Participants will receive three single oral doses of an optimized tablet formulations of GDC-0853. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.
干预措施: GDC-0853 (Drug)
Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)
Participants will receive three single oral doses of an optimized tablet formulations of GDC-0853. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.
干预措施: Rabeprazole (Drug)
结局指标
主要结局
Extrapolated Area Under the Curve (AUC Percent [%] Extrap) of GDC-0853
时间窗: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Maximum Observed Plasma Concentration (Cmax) of GDC-0853
时间窗: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of GDC-0853
时间窗: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Relative Bioavailability (Frel) of GDC-0853
时间窗: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Area Under the Curve From Time Zero to Last Measurable Concentration [AUC (0-t)] of GDC-0853
时间窗: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Time to Reach Maximum Observed Plasma Concentration (Tmax) of GDC-0853
时间窗: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Apparent Volume of Distribution (Vz/F) of GDC-0853
时间窗: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Apparent Terminal Elimination Half-Life (t1/2) of GDC-0853
时间窗: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Apparent Terminal Elimination Rate Constant of GDC-0853
时间窗: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
Apparent Oral Clearance (CL/F) of GDC-0853
时间窗: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
次要结局
- Percentage of Participants With Adverse Events (AEs)(From screening to the end of the study (approximately a maximum of 11 weeks))