NCT04178577已完成1 期
A Phase 1, Open-Label Study to Assess the Pharmacokinetics and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various 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
- 39
- 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 TBPM-PI-HBr 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
- •Adult males or females, 18 years of age or older.
- •BMI ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg
- •Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with Renal Disease).
- •Non-smoker for at least 1 month prior to screening for the study.
- •Ability and willingness to abstain from alcohol, caffeine, xanthinecontaining beverages or food.
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 of known or suspected Clostridium difficile infection.
- •History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic academia).
- •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 virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibodies.
- •History of substance abuse or alcohol abuse.
- •Use of antacids within 24 hours prior to study drug administration.
- •Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication.
研究组 & 干预措施
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
Experimental
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.
干预措施: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax).
时间窗: 72 hours post dose
Time to the maximum plasma concentration (Tmax).
时间窗: 72 hours post dose
Terminal elimination half-life (t1/2).
时间窗: 72 hours post dose
Apparent total body clearance (CL/F).
时间窗: 72 hours post dose
Area under the curve from time zero to the last quantifiable sample (AUC0-last).
时间窗: 72 hours post dose
Area under the curve extrapolated to infinity (AUC0-∞).
时间窗: 72 hours post dose
Apparent steadystate volume of distribution (Vss/F).
时间窗: 72 hours post dose
次要结局
- For subjects on dialysis, the amount of the dose removed by hemodialysis (XHD) will be assessed.(Up to 1 day post dose - between start and end of hemodialysis.)
- Renal clearance (CLR)(72 hours post dose)
- Fraction of drug excreted in the urine expressed as a percentage of the TBPM-PI-HBr dose administered (Ae%).(72 hours post dose)
- Significant changes from baseline in physical examination.(14 days post last dose)
- Significant changes from baseline in vitals signs.(14 days post last dose)
- Significant changes from baseline in ECG(14 days post last dose)
- For subjects on dialysis, estimated hemodialysis clearance (CLHD) will be assessed.(Up to 1 day post dose - between start and end of hemodialysis.)
- Incidence of treatment-emergent AEs (including SAEs) categorized by severity and relationship to study drug.(14 days post last dose)
- Significant changes from baseline in clinical laboratory values.(14 days post last dose)
- Amount of drug excreted in the urine through 24 hours (Ae0-24), through 48 hours (Ae0-48) and through 72 hours (Ae0-72) for Cohorts 1-4.(72 hours post dose)
- For subjects on dialysis, the extraction ratio (ER) will be assessed.(Up to 1 day post dose - between start and end of hemodialysis.)
研究者
研究点 (1)
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