Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 67
- 主要终点
- Assessing incidence of treatment emergent AEs
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will participate in only one cohort during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •BMI : 18-30 kg/m2 (Body Mass Index [BMI] [kg/m2] = Body weight [kg] Height2 [m2])
- •Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
- •Medical history without major pathology
排除标准
- •Evidence of clinically relevant pathology
- •Mental handicap
- •History of relevant drug and/or food allergies
- •Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center
- •Smoking within 60 days prior to drug administration and through the follow-up visit
- •History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
研究组 & 干预措施
WCK 4873
100 to 1200 mg in tablets (the 100 mg dose cohort will receive half a tablet; higher dose cohorts will receive 1 or more tablets)
干预措施: WCK 4873 (Drug)
Placebo
Visually matching placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Assessing incidence of treatment emergent AEs
时间窗: Day 18
Incidence of treatment emergent AEs, abnormal clinical laboratory findings, variations in LFTs, abnormal physical examination findings, variations in vital signs and variations in 12-lead ECG
Evaluating PK parameters for profiling
时间窗: Day 4
PMN white blood cell concentrations of WCK 4873.
次要结局
未报告次要终点