NCT02218294已完成1 期
A Phase 1 Study to Evaluate the Absorption, Metabolism and Excretion of BCX4161 Following Administration of a Single, Oral Dose of [14C]-Radiolabelled BCX4161 to Healthy Male 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
- 7
- 试验地点
- 1
- 主要终点
- Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces
研究概览
简要总结
The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made by the body, the chemical composition of these metabolites and their profile over time in blood and urine will be determined.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Age 30 to 65 years of age (inclusive)
- •Body mass index of 18.0 to 32.0 kg/m2
- •Must be willing and able to communicate and participate in the whole study
- •Must provide written informed consent
- •A history of regular bowel movements
- •Must agree to use an adequate method of contraception
排除标准
- •Participation in a clinical research study within the previous 3 months
- •Current or history of any drug or alcohol abuse in the past 2 years or positive drugs of abuse screen
- •Current smokers
- •Radiation exposure, including that from the present study, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
- •Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality
- •Activated partial thromboplastin time or PT outside of normal laboratory limits
研究组 & 干预措施
[14C] BCX4161
Experimental
Includes a radiolabelled dose of [14C] BCX4161 and unlabelled BCX4161
干预措施: BCX4161 (Drug)
结局指标
主要结局
Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces
时间窗: Determined from samples drawn up to 14 days post-dose
次要结局
- Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations(Over the duration of the study, approximately 6 weeks from screening through follow-up)
- Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine(Determined from samples drawn up to 4 days post-dose)
- Plasma pharmacokinetics (Cmax, Tmax, Tlag, AUC(0-last), AUC(0-inf), CL/F, Vz/F, AUC%extrapolated,t1/2, as applicable for each analyte) of total radioactivity, BCX4161, [14C] BCX4161 and major metabolites of [14C] BCX4161(Data generated from samples drawn up to 7 days post-dose)
- Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161(Data generated from samples drawn up to 7 days post-dose)
研究者
研究点 (1)
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