The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

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 : 18-30 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 Exclusion Criteria: 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)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WCK 4873<br>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) | Drug: WCK 4873<br>* 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)<br>|
| Placebo Comparator: Placebo<br>Visually matching placebo | Drug: Placebo Oral Tablet<br>* Visually matching placebo<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 | 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 | Day 18 | 
| Evaluating PK parameters for profiling | plasma PK parameters -Area under curve (AUC0-t, AUC0-12, AUC0-24, AUC0-inf, %AUC) | Day 4 | 
| Evaluating PK parameters for profiling | plasma PK parameters- maximum concentration (Cmax, Clast) | Day 4 | 
| Evaluating PK parameters for profiling | plasma PK parameters tmax, tlast, kel, t½, | Day 4 | 
| Evaluating PK parameters for profiling | urine PK paramters (Aeurine) | Day 4 | 
| Evaluating PK parameters for profiling | feces PK paramters ( Aefeces) | Day 4 | 
| Evaluating PK parameters for profiling | PMN white blood cell concentrations of WCK 4873. | Day 4 |