Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: WCK 4873
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WCK 4873<br>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 | Drug: WCK 4873<br> <br> |
| Placebo Comparator: Placebo<br>Visually matching placebo | Drug: Placebo Oral Tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing incidence of treatment emergent AEs | By abnormal clinical laboratory (including liver function tests) findings | Day 24 | 
| Assessing incidence of treatment emergent AEs | By variation in physical examination | Day 24 | 
| Assessing incidence of treatment emergent AEs | By abnormal findings in eye movement test and visual acuity test | Day 24 | 
| Assessing incidence of treatment emergent AEs | By abnormal vital signs | Day 24 | 
| Assessing incidence of treatment emergent AEs | variations in 12-lead electrocardiogram | Day 24 | 
| Measure the pharmacokinetic parameter: Area Under Curve (AUC) | plasma PK parameters area under curve (AUC) | Day 10 | 
| Measure the pharmacokinetic parameter-plasma PK concentration | Plasma concentration -Cmax | Day 10 | 
| Measure the pharmacokinetic parameter- Time | Plasma PK parameter- Tmax | Day 10 | 
| Measure the pharmacokinetic parameter- Time | Plasma PK parameter- T1/2 | Day 10 |