Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Oral Doses Of 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
- 30
- 主要终点
- Measure the pharmacokinetic parameter- Time
研究概览
简要总结
This is a Phase 1, randomized, double-blind, single center, placebo-controlled, sequential cohort study in a maximum of 3 cohorts of 10 healthy male and/or female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple oral doses of WCK 4873 or matching placebo once daily on Days 1 to 7. Dosing will be conducted under fed conditions on each dosing day. The dose levels to be administered will be based on the safety, tolerability and PK results of the single dose and food effect study (W 4873 01 study; PRA-code WOE384EC-123841).
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
- Triple (Participant, Care Provider, Investigator)
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 : 18.0-30.0 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, "power-drinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
- •Medical history without major pathology as judged by the Principal Investigator
- •Resting supine blood pressure 90-139 (systolic) / 40-89 (diastolic) mmHg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations as judged by the Principal Investigator
- •Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal -Investigator. QTcF should be <450 ms
排除标准
- •Previous participation in the current study
- •Evidence of clinically relevant pathology
- •Mental handicap
- •History of Myasthenia Gravis
- •History of hepatitis and/or jaundice associated with the use of any antibiotic
- •Congenital prolongation of the QTc interval, ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia
- •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
200 and 400 mg tablets Dosage form : Oral tablets Doses : To be determined based on the safety, tolerability and PK results of the single dose and food effect study
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
Measure the pharmacokinetic parameter- Time
时间窗: Day 10
Plasma PK parameter- T1/2
Measure the pharmacokinetic parameter-plasma PK concentration
时间窗: Day 10
Plasma concentration -Cmax
Measure the pharmacokinetic parameter: Area Under Curve (AUC)
时间窗: Day 10
plasma PK parameters area under curve (AUC)
Assessing incidence of treatment emergent AEs
时间窗: Day 24
variations in 12-lead electrocardiogram
次要结局
未报告次要终点