NCT06738836已完成1 期
An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EDG-7500 Following Single-Dose Oral Administration
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
- 8
- 试验地点
- 1
- 主要终点
- Mass Balance
研究概览
简要总结
The purpose of this study is to:
- Assess the mass balance (i.e., the cumulative elimination of 14C-related material in urine and feces, compared to the administered amount of radioactive isotope) of [14C]-EDG-7500 following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.
- Characterize the pharmacokinetics of EDG-7500 in plasma and of 14C-related material in whole blood, plasma, urine and feces following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Biological males ≥ 18.0 and < 55.0 years of age at time of providing Informed Consent.
- •Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening.
- •Subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
- •is documented to be surgically sterile (i.e., successfully vasectomized); or
- •agrees to use double-barrier contraception for at least 3 months after receiving study drug and agrees to refrain from sperm donation from the time of Screening through 3 months post dose.
- •Negative for hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody and antigen.
- •Non-smoker
排除标准
- •Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG or laboratory tests at Screening, Admission or predose on Day
- •Any history of serious allergic/hypersensitivity reactions.
- •History or presence of alcohol or drug abuse within 2 years prior to Screening.
- •Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void. Usual habit of < 1 or > 3 bowel movements per day.
- •Exposure to radiation for therapeutic or diagnostic reasons (except dental X rays and plain X rays of the thorax and bony skeleton) within the past 12 months .
- •Participation in another clinical study in which a [14C]-labeled drug was administered within 1 year prior to Admission.
- •QTcF interval (QT interval corrected for heart rate per Fridericia's formula) > 450 msec at Screening, Admission or predose on Day
- •Personal and family history of long QT syndrome or unexplained sudden death in a first-degree relative under 50 years of age.
- •Glomerular filtration rate (GFR) < 80 mL/min/1.73 m2
- •Loss or donation of blood (approximately 500 mL or greater) within 60 days prior to study drug administration on Day 1; donation of bone marrow or peripheral stem cells within 90 days prior to study drug administration on Day 1; or donation of plasma within 30 days prior to study drug administration on Day
- •Additional protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Human AME
Experimental
干预措施: [14C]-EDG-7500 (Drug)
结局指标
主要结局
Mass Balance
时间窗: From Day -1 through study completion (up to 19 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Cmax
时间窗: From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Tmax
时间窗: From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by T1/2
时间窗: From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by AUC0-inf
时间窗: From Day 1 to study completion (up to 18 days)
次要结局
- Metabolite profile(From Day -1 through study completion (up to 19 days))
- Safety as measured by occurrence of adverse events, clinical laboratory evaluations, 12-lead ECG and vital sign measurements(From screening through study completion (up to 54 days))
研究者
研究点 (1)
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