A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravenous and Oral Doses of Omadacycline in Pediatric Subjects With Suspected or Confirmed Bacterial Infections
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 9
- 主要终点
- Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, age 8 to < 18 (inclusive) who have written and signed parental/legal authorized representative (LAR) informed consent and pediatric assent.
- •Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline.
- •Weight within the 5th and 95th percentile for age and sex.
- •Subjects must not be pregnant or nursing at the time of enrollment, and must agree to use a highly effective birth control method during the study
排除标准
- •Evidence of a medical condition that may pose a safety risk or impair study participation.
- •Confirmed or suspected SARS-CoV-2 infection.
- •Has a history of hypersensitivity or allergic reaction to any tetracycline antibiotic.
- •Has received an investigational drug within the past 30 days.
研究组 & 干预措施
Cohort 2 (children)
8 to < 12 years of age
干预措施: Omadacycline Oral Tablet (Drug)
Cohort 1 (adolescents)
12 to < 18 years of age
干预措施: Omadacycline Injection [Nuzyra] (Drug)
Cohort 1 (adolescents)
12 to < 18 years of age
干预措施: Omadacycline Oral Tablet (Drug)
Cohort 2 (children)
8 to < 12 years of age
干预措施: Omadacycline Injection [Nuzyra] (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion
时间窗: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion
Blood samples were collected and analyzed to determine the AUC(0-48). Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
AUC(0-48) of Omadacycline After Oral Administration
时间窗: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine the AUC0-48. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion
时间窗: Pre-dose (At least 15 minutes prior to IV infusion), and 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion
Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
AUClast of Omadacycline After Oral Administration
时间窗: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine the AUClast. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion
时间窗: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion
Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
AUC0-inf of Omadacycline After Oral Administration
时间窗: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine AUC0-inf. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Maximum Observed Plasma Concentration (Cmax) of Omadacycline After IV Infusion
时间窗: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion
Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Cmax of Omadacycline After Oral Administration
时间窗: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine Cmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Omadacycline After IV Infusion
时间窗: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion
Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Tmax of Omadacycline After Oral Administration
时间窗: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine Tmax. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (t1/2) of Omadacycline After IV Infusion
时间窗: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion
Blood samples were collected and analyzed to determine t1/2 and was calculated by using formula. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
t1/2 of Omadacycline After Oral Administration
时间窗: Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing
Blood samples were collected and analyzed to determine t1/2. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Apparent Volume of Distribution During the Terminal Phase (Vz) of Omadacycline After IV Infusion
时间窗: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion
Blood samples were collected and analyzed to determine Vz. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
Systemic Clearance (CL) of Omadacycline After IV Infusion
时间窗: Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion
Blood samples were collected and analyzed to determine CL. Pharmacokinetic parameters were estimated using non-compartmental methods and actual time data.
次要结局
- Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), by Relationship to the Study Drug.(Up to Day 7)
- Number of Participants Reporting TEAE by Severity(Up to Day 7)
- Number of Participants With Clinically Significant Changes in Physical Examination(Up to Day 2)
- Number of Participants Reporting TEAE, Serious Adverse Events (SAEs) and AE Leading to Discontinuation of Study Drug(Up to Day 7)
- Number of Participants With Change From Baseline in Hematology Parameters(Up to Day 2)
- Number of Participants With Change From Baseline in Serum Chemistry Parameters(Up to Day 2)
- Number of Participants With Change From Baseline in Vital Signs(Up to Day 2)