A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0980 Following Single Oral Dose Administration in Healthy Postmenopausal Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 主要终点
- Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: maximum observed concentration (Cmax)
研究概览
简要总结
This study will be an open-label, non-randomized, absorption, metabolism, and excretion study of [14C]-GDC-0980 administered as a 10-mg oral dose to 6 healthy postmenopausal and/or surgically sterile female subjects following at least a 10-hour fast from food (not including water).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 是
入选标准
- •Medically healthy as determined by the absence of clinically significant findings in the medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
- •Female subjects of non-childbearing potential, as defined as either: postmenopausal and without recent history of menorrhea as documented either by physician note or confirmed by serum follicle-stimulating hormone level consistent with postmenopausal status, or surgically sterile
- •BMI range within 18.5 to 29.9 kg/m2, inclusive
- •Negative test for selected drugs of abuse at Screening and at Check-in
- •Negative hepatitis panel (including hepatitis B surface antigen [HBsAg], hepatitis C virus antibody [anti-HCV] and negative HIV antibody screens
- •Minimum of 1 to 2 bowel movements 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
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- •History or presence of inflammatory diseases, including those with small or large intestine inflammation such as Crohn's disease or ulcerative colitis, which required immunosuppressants
- •Use of potent proton-pump inhibitors such as omeprazole, lansoprazole, dexlansoprazole, esomeprazole, pantoprazole, and rabeprazole
- •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 to Check-in
- •Participation in more than one other radiolabeled investigational study drug trial within 12 months prior to Check-in. The previous radiolabeled study drug must have been received more than 6 months prior to Check-in for this study and the total exposure from this study and the previous study will be within the recommended levels considered safe
- •Exposure to significant radiation 12 months prior to Check-in
- •Use of any tobacco-containing or nicotine-containing products within 3 months/approximately 90 days prior to Check-in or positive urine screening for cotinine
- •Participation in any other investigational study drug 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, unless deemed acceptable by the Investigator
- •Use of any over-the-counter (OTC), non-prescription preparations within 7 days prior to Check-in
- •Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours
- •Poor peripheral venous access
- •Donation of blood from 30 days prior to Screening or of plasma from 2 weeks prior to Screening
- •Receipt of blood products within 2 months prior to Check-in
- •Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study
研究组 & 干预措施
A
[14C]-GDC-0980 administered as a 10-mg oral dose
干预措施: [14C]-GDC-0980 (Drug)
结局指标
主要结局
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: maximum observed concentration (Cmax)
时间窗: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: time to maximum concentration (tmax)
时间窗: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent total clearance
时间窗: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal elimination half-life (t1/2)
时间窗: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t)
时间窗: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: area under the concentration-time curve extrapolated to infinity
时间窗: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal phase elimination rate constant
时间窗: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent volume of distribution
时间窗: up to approximately 5 weeks
次要结局
- Pharmacokinetic based on the urine radioactivity concentrations: percent excreted in urine(up to approximately 5 weeks)
- Pharmacokinetic parameters for the metabolites of [14C]-GDC-0980 calculated based on plasma, urine, and fecal concentration levels.(up to approximately 5 weeks)
- Pharmacokinetic based on the urine radioactivity concentrations: amount of drug excreted in the urine over sampling interval(up to approximately 5 weeks)
- Pharmacokinetic based on the urine radioactivity concentrations: renal clearance(up to approximately 5 weeks)