A Mass Balance Study to Investigate the Absorption, Metabolism, Excretion of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371- Microtracer Dose in Healthy Male Subjects
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
- Assess the AME of LCB01-0371
研究概览
简要总结
The primary objectives of the study are:
• To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects
详细描述
This is a single-center, open-label, non-randomized, one-sequence, one-period, single arm study in healthy male subjects. A total of 6 subjects will be enrolled in the study, and a minimum of 4 evaluable subjects are considered sufficient. An evaluable subject is defined as a subject who has provided whole blood, plasma, exhalation and excreta samples sufficient for evaluation of the primary objectives. Study subjects will be screened for eligibility to participate in the study within 28 days before dosing.
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
- 19 Years 至 46 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults aged 19 to 45 (inclusive) years
- •Body weight at least 55 kg and calculated Body Mass Index (BMI) ranging from 18.0 to 25.0 kg/m2
- •Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form
- •Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.
- •Subject who were not to have a history of drug hypersensitivity or allergic reactions related to antibiotics, etc
排除标准
- •Subjects who had a clinically significant disease or a past history of disease
- •Subjects who had a past history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may have affected to absorption for the study drug.
- •Subjects who had the following laboratory test results at screening; AST, ALT, and total bilirubin ≥ 1.5 times upper limit of normal or CK (Creatine Kinase) > 2.5 times upper limit of normal
- •Subjects who had history of drug abuse or showed a positive result on a drug screening urine test.
- •Subjects who showed a positive result for a serology test (HBsAg, Anti-HCV , HIV Ab, or VDRL), etc.
研究组 & 干预措施
LCB01-0371 dose with a [14C]-LCB01-0371-tracer
A mass balance study to investigate the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose in healthy male subjects
干预措施: LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose (Drug)
结局指标
主要结局
Assess the AME of LCB01-0371
时间窗: an average of 8 days (+ - 1 D)
To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a \[14C\]-LCB01-0371-tracer dose to healthy subjects. Blood, urine, feces, and expired air samples will be collected according to the following schedules 1. Blood: Plasma(20 points), Whole blood(2 points) 2. Urine : 11 points 3. Feces : 8 points 4. Expired air: 14points
次要结局
未报告次要终点