NCT03177278已完成1 期
A Phase 1, Open-Label Study to Assess the Metabolism, Excretion, and Mass Balance of [14C]-Plazomicin Following a Single IV Infusion in Healthy Adult Male Subjects
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
- 6
- 试验地点
- 1
- 主要终点
- Total radioactivity concentration equivalents in plasma and blood
研究概览
简要总结
This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of [14C]-plazomicin 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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Medically healthy, with no clinically significant medical history, physical examination findings, vital signs or ECG findings
排除标准
- •Use of tobacco- or nicotine-containing products
- •Has received radio-labeled substances or has been exposed to radiation sources within 12 months of dosing or is likely to receive radiation exposure or radioisotopes within 12 months of dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe
- •History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease
- •History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus
- •History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness
研究组 & 干预措施
Arm 1
Experimental
干预措施: [14C]-plazomicin (Drug)
结局指标
主要结局
Total radioactivity concentration equivalents in plasma and blood
时间窗: 15 days
Plazomicin concentrations in plasma and urine
时间窗: 15 days
Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis
时间窗: 15 days
次要结局
- Incidence and severity of adverse events(21 days)
- Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)(1 day)
- Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)(4 days)
- Physical examination(Screening)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Radiolabeled Study of AG-221 in Healthy Male Subjects.Healthy VolunteersNCT02443168Celgene8
已完成
1 期
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293Healthy VolunteersMass Balance StudyNCT02126514AstraZeneca12
已完成
1 期
Metabolism and Excretory of HSK21542 in Maintenance Hemodialysis PatientsChronic Kidney Disease PatientsNCT06238388Haisco Pharmaceutical Group Co., Ltd.6
已完成
1 期
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic MelanomaMalignant MelanomaNCT01164891Hoffmann-La Roche7
已完成
1 期
Study of RPT193 in Healthy Adult Male SubjectsHealthy Male SubjectsNCT06087978RAPT Therapeutics, Inc.7