NCT01924143已完成1 期
An Open-Label Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-9855 Following a Single Oral Dose Containing Approximately 100 µCi [14C]-Labeled TD-9855 (20 mg) in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855
研究概览
简要总结
The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]TD-9855
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, nonsmoking male subjects or healthy, nonsmoking female subjects not of childbearing potential, 18 to 50 years old, inclusive. Women are considered to be not of childbearing potential if they have had a hysterectomy or tubal ligation or are at least 2 years postmenopausal (follicle-stimulating hormone [FSH] >40 IU/mL)
- •Body mass index 19 to 31 kg/m2, inclusive, and weight at least 55 kg
- •Negative for hepatitis B, hepatitis C, and HIV antibody
排除标准
- •Have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, dermatologic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- •Subjects who, in the opinion of the investigator, are at risk for suicide or risk of harming others, or who score positive on the C-SSRS (item 2 or higher on ideation). Subjects with any history of suicide attempts
- •Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas])
- •Infrequent bowel movements (less than once per 24 hours) in the last 7 days prior to Day -
- •Subject is unable to provide a fecal sample prior to study drug dosing on Day -1 or Day 1.
研究组 & 干预措施
TD-9855
Experimental
干预措施: TD-9855 (Drug)
结局指标
主要结局
To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855
时间窗: 1-21 Days
Urinary and fecal recovery of total radioactivity. Whole blood and plasma concentrations of total radioactivity.
次要结局
- Pharmacokinetics of total drug-related material and TD-9855: Cmax(1-21 Days)
- PK: Tmax(1-21 Days)
- PK: amount excreted in urine (Ae)(1-21 Days)
- PK: AUCt(1-21 Days)
- PK: AUCinf(1-21 Days)
- PK: CL/F (Renal clearance)(1-21 Days)
- PK: Vz/F (oral volume of distribution during the terminal phase)(1-21 Days)
- PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf)(8-21 Days)
- Metabolic profiles in plasma and excreta(1-21 days)
研究者
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