A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0973 Following Single Oral Dose Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Pharmacokinetics: maximum observed concentration (Cmax)
研究概览
简要总结
This open-label, non-randomized study will assess the absorption, metabolism, and excretion of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a single dose of [14C]-GDC-0973.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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) between 18.5 and 29.9 kg/m2, inclusive
- •No clinically significant findings from medical history, 12-lead ECG, and vital signs and laboratory evaluations
- •Negative test for selected drugs of abuse
- •No infection with hepatitis B, hepatitis C, human immunodeficiency virus (HIV)
- •Sterile or agree to use an adequate contraception method
- •Historically able to produce a minimum of 1 bowel movement per day
排除标准
- •Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance unless approved by the Investigator
- •History of stomach or intestinal surgery or resection (including a cholecystectomy) that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and/or hernia repair will be allowed
- •History of Gilbert's Syndrome
- •History of diabetes mellitus and/or elevated fasting glucose at baseline
- •History or presence of an abnormal ECG
- •History of alcoholism or drug addiction within 1 year prior Check-in
- •Participation in more than one other radiolabeled investigational study drug trial within 12 months prior to Check-in
- •Exposure to significant radiation within 12 months prior to Check-in study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in
- •Use of any tobacco-containing or nicotine-containing products within 6 months prior to Check-in
- •Participation in any other investigational study drug or biologic agent trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in
- •Use of any prescription medications/products within 14 days prior to Check-in
研究组 & 干预措施
GDC-0973 Single Arm
干预措施: GDC-0973 (Drug)
结局指标
主要结局
Pharmacokinetics: maximum observed concentration (Cmax)
时间窗: approximately 8 weeks
Route of elimination of [14C]-GDC-0973
时间窗: approximately 8 weeks
Pharmacokinetics: area under the concentration-time curve
时间窗: approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase rate constant
时间窗: approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase half-life
时间窗: approximately 8 weeks
Pharmacokinetics: apparent total clearance
时间窗: approximately 8 weeks
Pharmacokinetics: apparent volume of distribution
时间窗: approximately 8 weeks
Pharmacokinetics: amount total radioactivity in whole blood/urine/feces
时间窗: approximately 8 weeks
Pharmacokinetics: time to maximum concentration (tmax)
时间窗: approximately 8 weeks
次要结局
- Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates(approximately 8 weeks)
- Pharmacokinetics: plasma concentration of GDC-0973(approximately 8 weeks)
- Safety: incidence of adverse events(approximately 8 weeks)