A Single-Dose, Fixed-Sequence, Two-Period, Two-Treatment Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-1211 Following an Intravenous Infusion and an Oral Dose of [14C]TD-1211 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
The purpose of this study is to determine TD-1211 is processed by the body.
详细描述
This study will provide information regarding the metabolic pathway of TD 1211, the need for evaluation of potential drug-drug interactions, the need for studies in special populations and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of TD 1211, providing further quantitative information on the disposition of TD 1211. The results from this study will allow a more comprehensive comparison between animal and human routes of elimination and metabolic profiles of TD 1211.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, nonsmoking male, 18 to 50 years old, inclusive.
- •Agrees to use a highly effective method of birth control.
- •Body mass index (BMI) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg.
- •Willing and able to give written informed consent.
排除标准
- •Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- •Hemoglobin <14.1 g/dL or hematocrit < 40.6% at Screening.
- •History of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities.
- •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]).
- •Participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).
研究组 & 干预措施
TD-1211 PO [C14]
TD-1211 PO [C14]
干预措施: TD-1211 PO [C14] (Drug)
TD-1211 IV [C14]
TD-1211 IV [C14]
干预措施: TD-1211 IV [C14] (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 0 to 168 hours postdose
Peak plasma concentration (Cmax)
时间窗: 0 to 168 hours postdose
Time to peak plasma concentration (Tmax)
时间窗: 0 to 168 hours postdose
Half-life (T 1/2)
时间窗: 0 to 168 hours postdose
Percent total recovery of radioactivity in blood, urine, and feces
时间窗: 0 to 312 hours postdose
次要结局
- Number of participants with adverse events(Baseline to 14 days)