VNRX-5133-103: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX-5133 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
研究概览
简要总结
This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.
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)
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
- •Males or non-pregnant, non-lactating females
- •Body Mass Index (BMI) between 18.5 - 32.0, inclusive
- •Weight greater than or equal to 50 kg
- •Suitable veins for cannulation
排除标准
- •Employee of site or the sponsor
- •Any disease that poses an unacceptable risk to participants
- •Abnormal ECG
- •Abnormal labs
- •Abnormal vital signs
- •Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
- •Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
研究组 & 干预措施
Part 1A
In Part 1A, subjects will receive single doses of VNRX-5133 and VNRX-5022 alone and in combination. All subjects will receive all treatments in the sequence specified by the randomization schedule..
干预措施: VNRX-5133 (Drug)
Part 1A
In Part 1A, subjects will receive single doses of VNRX-5133 and VNRX-5022 alone and in combination. All subjects will receive all treatments in the sequence specified by the randomization schedule..
干预措施: VNRX-5022 (Drug)
Part 1B
In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule.
干预措施: VNRX-5133 (Drug)
Part 1B
In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule.
干预措施: VNRX-5022 (Drug)
Part 1B
In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule.
干预措施: Metronidazole (Drug)
Part 2 - 2A
Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022
干预措施: VNRX-5133 (Drug)
Part 2 - 2A
Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022
干预措施: VNRX-5022 (Drug)
Part 2 - 2B
Multiple dose administration of High Dose VNRX-5133 + VNRX-5022
干预措施: VNRX-5133 (Drug)
Part 2 - 2B
Multiple dose administration of High Dose VNRX-5133 + VNRX-5022
干预措施: VNRX-5022 (Drug)
Part 2 - 2C
Multiple dose administration of Placebo (matching VNRX-5133 + VNRX-5022)
干预措施: Placebo (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
时间窗: 0-48 hours
Cmax
Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
时间窗: 0-48 hours
AUCinf
次要结局
- Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration(Part 2: 10 days)
- Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)(0-48 hours)
- Number of Subjects with Treatment Emergent Adverse Events(First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days)
- Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)(0-48 hours)