A PHASE 1 STUDY TO INVESTIGATE THE ABSOLUTE BIOAVAILABILITY OF GDC-0032 AND THE ABSORPTION, METABOLISM, AND EXCRETION OF [14C]-GDC-0032 IN HEALTHY MALE SUBJECTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval
研究概览
简要总结
This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;
- •Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
- •Agree to use effective contraceptive methods as defined by protocol;
- •Negative hepatitis panel and HIV screen;
- •Sufficient bowel movements (minimum of 1 per day).
排除标准
- •History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
- •History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
- •History of alcoholism or drug addiction within 1 year prior to drug administration;
- •Tobacco or nicotine use within 6 months prior to study start;
- •Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
- •Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption;
- •Inability or unwillingness to swallow capsules;
- •Participation in a drug study in which a drug was administered within 30 days prior to study start;
- •Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure;
- •Exposure to significant radiation within 12 months prior to study start.
研究组 & 干预措施
Bioavailability
干预措施: GDC-0032 (Drug)
Elimination & PK
干预措施: GDC-0032 (Drug)
结局指标
主要结局
Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval
时间窗: Days 1 to 22
Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces.
时间窗: Days 1 to 22
Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC])
时间窗: Days 1 to 11
Elimination & PK: Maximum concentration (Cmax) of GDC-0032
时间窗: Days 1 to 22
Elimination & PK: Area under the concentration-time curve (AUC)
时间窗: Days 1 to 22
次要结局
- Elimination & PK: Metabolite identification in plasma, urine, & feces(Days 1 to 22)
- Safety: Incidence of adverse events(38 to 49 days)