NCT03182504已完成1 期
A Non-Randomized, Open Label, One Treatment, One Group Study to Investigate the Intrapulmonary Lung Penetration of RO7079901 in Healthy Volunteers
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
- 21
- 试验地点
- 1
- 主要终点
- Epithelial Lining Fluid (ELF) Concentration of Nacubactam to Plasma Concentration of Nacubactam Ratio
研究概览
简要总结
The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being developed as a combination therapy with the beta-lactam meropenem for the treatment of serious gram-negative bacterial infections. Adult male and female healthy participants will receive a single intravenous infusion of nacubactam co-administered with meropenem and then undergo a bronchoalveolar lavage (BAL) procedure to collect lung epithelial lining fluid (ELF) for measurement of intrapulmonary concentrations of nacubactam and meropenem.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 60 years of age, inclusive
- •Healthy, as judged by the Investigator and defined by the absence of evidence of any active or clinically significant chronic disease identified from a detailed medical and surgical history, physical examination including vital signs and 12-lead electrocardiogram (ECG), and laboratory safety test results
- •Body mass index (BMI) within the range 18-30 kilogram per square meter (kg/m^2),inclusive
- •Non-smoker, or former smoker who has abstained from smoking for at least 6 months
- •Negative pregnancy test and agreement to comply with measures to prevent pregnancy in women
- •Refrain from sperm donation and agreement to comply with measures to prevent pregnancy in partner of childbearing potential for men
排除标准
- •History of asthma or clinically significant lung disease
- •Any condition which contraindicates a BAL procedure
- •History of clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, dermatological, immunological or allergic disease, metabolic disorder, cancer or cirrhosis
- •Clinically significant change in health status, as judged by the Investigator, or any major illness within the four weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening
- •History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders
- •Participation in any other clinical study involving an investigational medicinal product or device within 3 months before screening
- •Known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to any drug, in particular antibiotics
- •Donation or loss of over 500 milliliter (mL) of blood within the three months before screening
研究组 & 干预措施
Nacubactam Plus Meropenem
Experimental
Participants will receive a single dose of nacubactam co-administered with meropenem.
干预措施: nacubactam (Drug)
Nacubactam Plus Meropenem
Experimental
Participants will receive a single dose of nacubactam co-administered with meropenem.
干预措施: meropenem (Drug)
结局指标
主要结局
Epithelial Lining Fluid (ELF) Concentration of Nacubactam to Plasma Concentration of Nacubactam Ratio
时间窗: At 2, 3, 4, 6 and 8 hours after study drug administration
The ELF to plasma ratio will be calculated from the concentration of nacubactam in ELF and plasma as a measure of the intrapulmonary penetration of nacubactam in healthy participants.
次要结局
- Volume of Distribution of the Central Compartment (Vc) of Nacubactam(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Maximum Concentration (Cmax) of Meropenem in Blood Plasma(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Time to Reach the Maximum Plasma Concentration (Tmax) of Nacubactam(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Maximum Concentration (Cmax) of Nacubactam in ELF(At 2, 3, 4, 6 and 8 hours after study drug administration)
- Area Under the Plasma Concentration-Time Curve from Time 0 to 8 Hours (AUC0-8) of Nacubactam in Blood Plasma(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Volume of Distribution at Steady-State (Vss) of Nacubactam(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Maximum Concentration (Cmax) of Meropenem in ELF(At 2, 3, 4, 6 and 8 hours after study drug administration)
- Clearance (CL) of Meropenem(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Volume of Distribution at Steady-State (Vss) of Meropenem(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Clearance (CL) of Nacubactam(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Time to Reach the Maximum Plasma Concentration (Tmax) of Meropenem(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- ELF Concentration of Meropenem to Plasma Concentration of Meropenem Ratio(At 2, 3, 4, 6 and 8 hours after study drug administration)
- Maximum Concentration (Cmax) of Nacubactam in Blood Plasma(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Area Under the Plasma Concentration-Time Curve from Time 0 to 8 Hours (AUC0-8) of Meropenem in ELF(At 2, 3, 4, 6 and 8 hours after study drug administration)
- Area Under the Plasma Concentration-Time Curve from Time 0 to 8 hours (AUC0-8) of Meropenem in Blood Plasma(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Area Under the Plasma Concentration-Time Curve from time 0 to 8 hours (AUC0-8) of Nacubactam in ELF(At 2, 3, 4, 6 and 8 hours after study drug administration)
- Volume of Distribution of the Central Compartment (Vc) of Meropenem(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
- Number of Participants with Adverse Events(From baseline up to 14 days after study drug administration)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy SubjectsHealthy SubjectsNCT04951505Venatorx Pharmaceuticals, Inc.30
已完成
2 期
Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDIAsthmaNCT01349257Chiesi Farmaceutici S.p.A.24
进行中（未招募）
3 期
Nipocalimab in Moderate to Severe Sjogren's DiseaseSjogrens SyndromeNCT06741969Janssen Research & Development, LLC655
已完成
1 期
A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's DiseaseHealthy Study ParticipantsParkinson's DiseaseNCT04867642UCB Biopharma SRL100
已完成
1 期
Intravenous Fosfomycin Pharmacokinetics StudyMultiple-drug ResistancePathogen ResistanceBacterial InfectionNCT03910673National Institute of Allergy and Infectious Diseases (NIAID)39