A Phase 1, Open-label Study in Healthy Male Subjects of the Absorption, Metabolism, Excretion, and Pharmacokinetics of EDG-5506 and an Absolute Bioavailability Study Using Radiolabeled EDG-5506
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine
研究概览
简要总结
This is a Phase 1 2-part, single-center, open-label study in healthy male volunteers. Part A will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of radiolabeled EDG-5506. Part B will assess bioavailability of EDG-5506 with a single oral dose of EDG-5506 and a single intravenous dose of radiolabeled EDG-5506.
详细描述
This is a Phase 1 2-part, single-center, open-label study.
Up to 15 (8 in Part A and 7 in Part B) healthy male subjects will be enrolled in the study.
Part A:
Potential subjects will be screened to assess eligibility within 28 days prior to dose administration. Subjects will be admitted on Day -1 and confined to the study site until at least Day 30. On Day 1, subjects will receive a single oral suspension. Blood, urine and feces samples will be collected for determination of EDG-5506 concentration, total radioactivity, and metabolite profiling and identification. Between Day 30 and Day 36, subjects will be discharged.
Part B:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •For both Part A and Part B, males, of any race, between 18 and 55 years of age, inclusive.
- •For both Part A and Part B, a body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight greater than or equal to 50 kg.
- •In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram, vital signs measurements, and clinical laboratory evaluations at screening and check-in.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, genitourinary, immunological, or psychiatric disorder, as determined by the investigator (or designee).
- •Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to dosing.
- •Participation in more than 3 radiolabeled drug studies in the last 12 months.
- •Poor peripheral venous access.
- •Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
研究组 & 干预措施
Part A - AME
Evaluation of absorption, metabolism, excretion and pharmacokinetics of a single oral dose of radiolabeled EDG-5506 in healthy male volunteers
干预措施: Radiolabeled EDG-5506 Suspension (Drug)
Part B - aBA
Evaluation of bioavailability of a single oral dose of EDG-5506 followed by a single intravenous dose of radiolabeled EDG-5506 in healthy male volunteers
干预措施: EDG-5506 Tablet (Drug)
Part B - aBA
Evaluation of bioavailability of a single oral dose of EDG-5506 followed by a single intravenous dose of radiolabeled EDG-5506 in healthy male volunteers
干预措施: Radiolabeled EDG-5506 Intravenous (Drug)
结局指标
主要结局
The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine
时间窗: Up to 37 days
Absolute bioavailability of EDG-5506 as measured by Fabs
时间窗: Up to 9 days
The mass balance of EDG-5506 as measured by the total radioactivity recovered in feces
时间窗: Up to 37 days
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506
时间窗: Up to 37 days
Characterization of EDG-5506 as measured by urinary recovery (fet1-t2)
时间窗: Up to 37 days
次要结局
- Incidence of abnormal clinical laboratory test results(Up to 37 days)
- Incidence of treatment-emergent adverse events(Up to 37 days)
- Incidence of abnormal electrocardiograms (ECGs)(Up to 37 days)
- Distribution of total radioactivity into blood cells as measured by whole blood to plasma concentration ratio(Up to 37 days)