VNRX-7145-102: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics (PK) of VNRX-7145 and VNRX-5024 (Ceftibuten) in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Parts 2&3: Number of subjects with adverse events
研究概览
简要总结
This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Part 1: Unblinded Parts 2&3: Blinded
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 18-55 years
- •Males or non-pregnant, non-lactating females
- •Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
- •Normal blood pressure
- •Normal lab tests
排除标准
- •History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
- •History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- •Use of antacid medications
- •Abnormal ECG or history of clinically significant abnormal rhythm disorder
- •Positive alcohol, drug, or tobacco use/test
研究组 & 干预措施
Part 1
Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule.
干预措施: VNRX-7145 (Drug)
Part 1
Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule.
干预措施: VNRX-5024 (ceftibuten) (Drug)
Part 2A
Multiple dose administration of VNRX-7145 q8h for 10 days
干预措施: VNRX-7145 (Drug)
Part 2B
Multiple dose administration of placebo q8h for 10 days
干预措施: Placebo (Drug)
Part 3A
Multiple dose administration of low dose VNRX-7145 + VNRX-5024
干预措施: VNRX-7145 (Drug)
Part 3A
Multiple dose administration of low dose VNRX-7145 + VNRX-5024
干预措施: VNRX-5024 (ceftibuten) (Drug)
Part 3B
Multiple dose administration of high dose VNRX-7145 + VNRX-5024
干预措施: VNRX-7145 (Drug)
Part 3B
Multiple dose administration of high dose VNRX-7145 + VNRX-5024
干预措施: VNRX-5024 (ceftibuten) (Drug)
Part 3C
Multiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024)
干预措施: Placebo (Drug)
结局指标
主要结局
Parts 2&3: Number of subjects with adverse events
时间窗: Day 15 (+2)
Part 1: AUC0-inf
时间窗: 0-48 hours
Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK
Part 1: Cmax
时间窗: 0-48 hours
concentration time data
次要结局
- Parts 2&3: AUC0-tau(Day 10)
- Parts 2&3: Cmax(Day 10)
- Part 1: Number of subjects with adverse events(Day 14 (+2))