An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]-STX-478 Following Single-Dose Oral Administration
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
- Percentage of the Total Radioactive Dose in Urinary, Fecal, and Urinary and Fecal Combined Excretion
研究概览
简要总结
The main purpose of this study is to conduct blood tests to measure how much STX-478 is in the bloodstream and how the body handles and eliminates it in healthy participants. This study will involve a single dose of 14C radiolabeled STX-478. This means that a radioactive tracer substance, C14, will be incorporated into the study drug STX-478 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of STX-478.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
- •Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) and human immunodeficiency virus antibody and antigen (HIV Ab/Ag).
- •Non-smoker (with no use of other tobacco or nicotine containing products, in any form), as documented by history (no nicotine within 6 months prior to Screening) and a negative cotinine test at Screening and admission
排除标准
- •History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
- •Any history of serious allergic/hypersensitivity reactions
- •History or presence of alcohol or drug abuse (self-reported) within 2 years prior to Screening.
- •Administration of any prescription or non-prescription drugs (including antacids; however, acetaminophen at a dose ≤ 1 g/day is permitted), herbal remedies or vitamin supplements from 28 days, or five half-lives, whichever is longer, prior to Admission.
研究组 & 干预措施
[14C]-STX-478
Healthy participants will receive a single dose of [14C]-STX-478.
干预措施: [14C]-STX-478 (Drug)
结局指标
主要结局
Percentage of the Total Radioactive Dose in Urinary, Fecal, and Urinary and Fecal Combined Excretion
时间窗: Baseline, Up to Day 29
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of 14C and STX-478(Predose up to Day 29 Post Dose)
- PK: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC 0- inf) of 14C and STX-478(Predose up to Day 29 Post Dose)
- Total Radioactivity Recovered in Urine and Feces(Predose up to Day 29 Post Dose)
- Total Number of Metabolites and Identification of Metabolites of STX-478 in Plasma, Urine, and Feces(Predose up to Day 29 Post Dose)