VNRX-7145-104: an Open-label, Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Healthy Participants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 18-65 years
- •Males or non-pregnant, non-lactating females
- •Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
- •Laboratory values meeting defined entry criteria
排除标准
- •History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug
- •Conditions that potentially alter absorption and/or excretion of orally administered drugs
- •Congenital or acquired immunodeficiency syndrome
- •Positive alcohol, drug, or tobacco use/test
研究组 & 干预措施
Cohort 1
Cohort 1 will assess the impact of a high fat meal.
干预措施: VNRX-7145 (Drug)
Cohort 1
Cohort 1 will assess the impact of a high fat meal.
干预措施: Ceftibuten (Drug)
Cohort 2
Cohort 2 will be conducted to assess the impact of an alternative lower fat meal if administration with high fat meal has a food effect on drug exposure.
干预措施: VNRX-7145 (Drug)
Cohort 2
Cohort 2 will be conducted to assess the impact of an alternative lower fat meal if administration with high fat meal has a food effect on drug exposure.
干预措施: Ceftibuten (Drug)
Cohort 3
Cohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure.
干预措施: VNRX-7145 (Drug)
Cohort 3
Cohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure.
干预措施: Ceftibuten (Drug)
结局指标
主要结局
Cmax
时间窗: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
Maximum observed plasma concentration (Cmax)
AUC0-t
时间窗: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
Area under the plasma concentration-time curve (AUC) from time 0 up to the last quantifiable concentration at time t (AUC0-t)
AUC0-inf
时间窗: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
AUC from time 0 extrapolated to infinity (AUC0-inf)
次要结局
未报告次要终点