NCT04865393已完成1 期
A Phase 1, Open-label Study to Assess the Safety and Pharmacokinetics of SPR206 Following a Single IV Dose of SPR206 in Subjects With Varying Degrees of Renal Function
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
- 37
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg (inclusive)
- •Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with varying degrees of Renal Disease)
- •Normal renal function with eGFR ≥90 mL/min/1.73m2 (Cohort 1), or renal insufficiency with eGFR 60 to <90 mL/min/1.73m2 (Cohort 2), 30 to <60 mL/min/1.73m2 (Cohort 3), or <30 mL/min/1.73m2 (Cohort 4), calculated using Modification of Diet in Renal Disease (MDRD). Subjects with ESRD must be receiving hemodialysis at least 3 times per week for at least 3 months at Screening (Cohort 5 only)
- •Non-smoker for at least 1 month prior to screening for the study
- •Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food
- •Other inclusion criteria per protocol
排除标准
- •Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
- •Electrocardiogram (ECG) with QTcF interval duration equal or greater than 500 msec
- •Hemoglobin (HB), hematocrit (HCT), white blood cell count (WBC), or platelet count less than the lower limit of normal range of the reference laboratory (Cohort 1). HB <8.5 gm/dL, WBC ≤3,000 cells/μL or platelet count ≤100,000 cells/μL (Cohorts 2-5)
- •Results of biochemistry tests for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin greater than 1.5 X the upper limit of normal (ULN) for the reference laboratory
- •Recent history (within 6 months) of known or suspected Clostridium difficile infection
- •History of chronic liver disease, cirrhosis, or biliary disease
- •History of seizure disorder except childhood history of febrile seizures
- •Positive urine drug/alcohol testing
- •Positive testing for human immunodeficiency virus1/2 (HIV 1/2), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibodies
- •History of substance abuse or alcohol abuse
- •Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
- •Other exclusion criteria per protocol
研究组 & 干预措施
SPR206
Experimental
SPR206 100mg single-dose IV infused over 1 hour
干预措施: SPR206 (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: 36 hours after start of study drug IV infusion
Area under the concentration-time curve from time 0 to last measurable timepoint (AUC0-t)
时间窗: 36 hours after start of study drug IV infusion
Time to the maximum plasma concentration (Tmax)
时间窗: 36 hours after start of study drug IV infusion
Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
时间窗: 36 hours after start of study drug IV infusion
次要结局
- Terminal Elimination Rate Constant (kel)(36 hours after start of study drug IV infusion)
- Incidence of abnormal vital sign assessments - body temperature(14 days post study drug IV infusion)
- Cumulative amount of drug excreted in urine at the end of each interval (Aeu) for Cohorts 1-4(36 hours after start of study drug IV infusion)
- Amount of the dose removed by hemodialysis (XHD) for subjects on dialysis (Cohort 5)(Up to 1 day post dose - between start and end of hemodialysis)
- Incidence of abnormal ECG assessments - heart rate(14 days post study drug IV infusion)
- Total body clearance (CL)(36 hours after start of study drug IV infusion)
- Area under the concentration-time curve from time 0 to 8 hours (AUC0-8)(8 hours after start of study drug IV infusion)
- Terminal half-life (t1/2)(36 hours after start of study drug IV infusion)
- Fraction of drug excreted in the urine expressed as a percentage (Ae%) for Cohorts 1-4(36 hours after start of study drug IV infusion)
- Fraction of dose excreted in the urine over a collection interval (Fe) for Cohorts 1-4(36 hours after start of study drug IV infusion)
- Extraction ratio (ER) for subjects on dialysis (Cohort 5)(Up to 1 day post dose - between start and end of hemodialysis)
- Estimated hemodialysis clearance (CLHD) for subjects on dialysis (Cohort 5)(Up to 1 day post dose - between start and end of hemodialysis)
- Incidence of abnormal physical exam assessments(14 days post study drug IV infusion)
- Incidence of abnormal safety laboratory assessments(14 days post study drug IV infusion)
- Renal clearance (CLR)(36 hours after start of study drug IV infusion)
- Steady-state volume of distribution (Vss)(36 hours after start of study drug IV infusion)
- Amount of drug excreted in urine by interval (Aet) for Cohorts 1-4(36 hours after start of study drug IV infusion)
- Cumulative fraction of dose excreted in the urine over (Feu) for Cohorts 1-4(36 hours after start of study drug IV infusion)
- Incidence of Treatment-Emergent Adverse Events(14 days post start of last study drug IV infusion)
- Incidence of abnormal vital sign assessments - blood pressure(14 days post study drug IV infusion)
- Incidence of abnormal ECG assessments - PR, RR, QRS, QT and QTcF interval(14 days post study drug IV infusion)
研究者
研究点 (1)
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