A Non-Randomized, Open-Label, One Treatment, One Group Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Patients With a Complicated Urinary Tract Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- Total Clearance (CL) of RO7079901
研究概览
简要总结
This is a non-randomized, open-label, one-treatment, one group study in participants with complicated urinary tract infection (cUTI) including pyelonephritis to characterize the pharmacokinetics of RO7079901 co-administered with 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requiring hospitalization for IV antibacterial therapy for the treatment of presumed/confirmed cUTI (including pyelonephritis)
- •Clinical signs and/or symptoms of pyelonephritis or a cUTI
- •Urine culture taken within the 48 hours (hr) period immediately preceding the first dose of study drug contains greater than (>)1x10^5 colony forming units (CFU) per milliliter (CFU/mL) of a gram negative organism
- •Negative urine pregnancy test result confirmed by a blood test
- •Agreement to remain abstinent or use a contraceptive method
排除标准
- •Has a concomitant infection requiring antibacterial therapy, in addition to study drug
- •Confirmed fungal urinary tract infection
- •Moderate or severe renal impairment, or end-stage renal disease requiring renal replacement therapy or a recipient of a renal transplant
- •Documented presence of immunodeficiency, or a severely immunocompromised condition or use of systemic immunosuppressant therapy
- •Any rapidly progressing disease or immediately life-threatening illness, or other terminal illness or condition with high risk of mortality meaning that the participant is considered, in the opinion of the Investigator, unlikely to survive the study period
- •Urinary tract surgery or clinically significant urogenital trauma in the one week immediately preceding study entry
- •Urinary tract infection (UTI) symptoms potentially attributable to another process (sexually transmitted infections or prostatitis)
- •Suspected or confirmed perinephric or intra renal abscess
- •Complete obstruction of any portion of the urinary tract, or a permanent urinary diversion
- •History of epilepsy, brain lesions or other significant neurological disorders
- •Use of probenecid within the 7 days before enrollment
- •Known history of clinically significant hypersensitivity or severe allergic reaction to meropenem or any other antibiotic
- •Any other ongoing condition or disease, or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study
- •Women who are pregnant, planning to become pregnant, or lactating
- •Participation in a clinical study of an investigational drug or device within one month prior to enrollment
- •Prior enrollment in this study
研究组 & 干预措施
RO7079901 and Meropenem
Participants will receive RO7079901 and meropenem. The duration of study drug treatment will be determined by the investigator after evaluation of the participant's response to study drug treatment. Participants should receive a minimum treatment period of 3 days and up to 14 days of intravenous (IV) study drug treatment.
干预措施: RO7079901 (Drug)
RO7079901 and Meropenem
Participants will receive RO7079901 and meropenem. The duration of study drug treatment will be determined by the investigator after evaluation of the participant's response to study drug treatment. Participants should receive a minimum treatment period of 3 days and up to 14 days of intravenous (IV) study drug treatment.
干预措施: Meropenem (Drug)
结局指标
主要结局
Total Clearance (CL) of RO7079901
时间窗: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Renal Clearance (CLr) of RO7079901
时间窗: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Maximum Observed Plasma Concentration (Cmax) of RO7079901
时间窗: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Fraction Excreted into the Urine (Fe) of RO7079901
时间窗: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
Time of Maximum Observed Plasma Concentration (Tmax) of RO7079901
时间窗: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Steady State Volume of Distribution (Vss) of RO7079901
时间窗: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUC0-tau) of RO7079901
时间窗: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
Cumulative Amount Excreted in Urine Over the Dosing Interval (Ae) of RO7079901
时间窗: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
次要结局
- Cmax of Meropenem(Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7)
- Ae of Meropenem(Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected))
- CL of Meropenem(Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7)
- CLr of Meropenem(Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected))
- AUC0-tau of Meropenem(Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7)
- Fe of Meropenem(Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected))
- Tmax of Meropenem(Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7)
- Vss of Meropenem(Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7)