A 2-Cohort Study to Evaluate the Absolute Bioavailability, Absorption, Distribution, Metabolism and Excretion of TD-1473 Following an Intravenous and an Oral Dose of [14C]-TD-1473 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Absolute bioavailability (%F) in Plasma
研究概览
简要总结
This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of [14C]-TD-1473. Subjects in cohort 2 will receive a single oral dose of [14C]-TD-1473 only.
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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is a healthy, nonsmoking male, 19 to 55 years old, inclusive
- •Subject has a body mass index (BMI) 19 to 32 kg/m2, inclusive, and weighs at least 50 kg
- •Subject is healthy as determined by the PI or designee based on medical history and physical examination performed at Screening and Day -1
- •Additional inclusion criteria apply
排除标准
- •Subject has 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])
- •Subject has a known hypersensitivity towards medications similar to TD 1473 or excipients contained in TD 1473
- •Subject regularly works with ionizing radiation or radioactive material
- •Subject has been exposed to ionizing radiations, within 1 year prior to the start of the study, as external irradiation (i.e., radiological examination including CT scan, excluding dental radiography) or internal radiation (i.e., diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months
- •Subject, who, for any reason, is deemed by the PI or designee or Sponsor to be inappropriate for this study or have any condition which would confound or interfere with the evaluation of the safety, tolerability, and PK of the investigational drug or prevent compliance with the study protocol
- •Additional exclusion criteria apply
研究组 & 干预措施
TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus
Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473
干预措施: TD-1473 oral capsule (Drug)
TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus
Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473
干预措施: [14C]-TD-1473 IV bolus (Drug)
[14C]-TD-1473 Oral Capsule
Cohort 2 - One oral dose
干预措施: [14C]-TD-1473 Oral Capsule (Drug)
结局指标
主要结局
Absolute bioavailability (%F) in Plasma
时间窗: Up to 15 days
Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma
时间窗: Up to 15 days
Apparent terminal elimination half-life (t1/2) in Plasma
时间窗: Up to 15 days
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma
时间窗: Up to 15 days
Apparent volume of distribution (Vz/F) in Plasma
时间窗: Up to 15 days
Maximum observed concentration (Cmax) in Plasma
时间窗: Up to 15 days
Time to maximum observed concentration (tmax) in Plasma
时间窗: Up to 15 days
Apparent clearance (Cl/F) in Plasma
时间窗: Up to 15 days
次要结局
- Amount excreted in feces (Aef) over the sampling interval in Feces(Up to 15 days)
- Amount excreted in urine (Aeu) over the sampling interval in Urine(Up to 15 days)
- Renal clearance (CLr) in Urine(Up to 15 days)
- The percent excreted in urine (%Feu) in Urine(Up to 15 days)
- The percent excreted in feces (%Fef)(Up to 15 days)