A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 Following Single Intravenous Dose Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Trevena Inc.
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130
研究概览
简要总结
The purpose of this study is to determine the routes of excretion for TRV130 and it's metabolites, and to determine and characterize, structurally, the metabolites present in plasma, urine, and feces in healthy male subjects.
详细描述
This study is an open-label, non-randomized, metabolism and excretion study of a single 2 mg IV dose of [14C] TRV130 (approximately 100 µCi) administered as a 10 mL manual IV push over 2 minutes in a fasted state.
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 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males, between 18 and 64 years of age, inclusive
- •With body weight ≥ 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- •Negative test for selected drugs of abuse at Screening and at Check-in
- •Able to comprehend and willing to sign an Informed Consent Form (ICF) prior to any study procedure
- •A typical minimum of 1 to 2 bowel movements per day
排除标准
- •History of sensitivity to any of the study medications or components thereof or a history of medication or other allergy that, in the opinion of the Investigator, contraindicates their participation
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days prior to Check-in
- •Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in
- •Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check-in
- •Has current malignancy, current systemic chemotherapy, or cancer diagnosis within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin that has been clinically stable and fully excised in a curative procedure);
- •Use of any tobacco- or nicotine-containing products within 6 months prior to Screening
研究组 & 干预措施
Radiolabeled TRV130
干预措施: Radiolabeled TRV130 (Drug)
结局指标
主要结局
To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130
时间窗: Day 1 - Day 13
To determine whole blood concentrations of total radioactivity
时间窗: Day 1 - Day 13
To determine plasma concentrations of total radioactivity
时间窗: Day 1 - Day 13
To determine urine concentrations of total radioactivity
时间窗: Day 1 - Day 13
To determine fecal concentration of total radioactivity
时间窗: Day 1 - Day 13
次要结局
- To identify metabolites associated with TRV130 in blood, urine and feces(Day 1 - Day 13)
- Number of patients experiencing an Adverse Event(Day 1 - Day 13)