An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone in Healthy Male Subjects After Oral Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Radioactivity concentration equivalents in plasma
研究概览
简要总结
This is an open label, single dose, 1 period study of [14C] galeterone.
详细描述
This is an open label, 1 period study under fed conditions. Six (6), healthy, adult, non tobacco using, male subjects will be enrolled. Screening of subjects will occur within 28 days prior to dosing. On Day 1, a single dose of radio-labeled galeterone will be administered orally. Blood, urine, and fecal samples will be collected until release criteria are met to measure total radioactivity, for analysis of galeterone concentrations, and for potential metabolic profiling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Healthy, adult, male, 19 to 55 years of age, inclusive, at screening.
- •Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing.
- •Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- •History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
研究组 & 干预措施
Single dose of [14C]-galeterone
[14C]-galeterone will be supplied as 325 mg capsules (powder in capsule [PIC]). The treatment to be administered will be 2600 mg (~500 µCi) (8 x 325 mg capsules).
干预措施: galeterone (Drug)
结局指标
主要结局
Radioactivity concentration equivalents in plasma
时间窗: 168 hours
Single dose galeterone concentrations in plasma
时间窗: 168 hours
Route(s) of elimination of a single [14C]galeterone dose
时间窗: 8 days
Ratio of whole blood to plasma 14C radioactivity
时间窗: 24 hours
Mass balance of a single [14C]galeterone dose
时间窗: 8 days
次要结局
未报告次要终点