Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects

Study Overview
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Brief Summary
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This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in healthy adult subjects.

Official Title
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A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects

Conditions
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Intrapulmonary Pharmacokinetics of WCK 2349

Intervention / Treatment
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* Drug: WCK-2349


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult males or females, 18 to 55 years of age (both inclusive) at the time of screening. Medical history without any major pathology as judged by the Principal Investigator. Exclusion Criteria: History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease. Positive urine drug/alcohol testing at screening or confinement. Positive testing for HIV, Hepatitis B or Hepatitis C. History or presence of alcohol or drug abuse within the 2 years prior to screening. Excessive intake of alcohol, defined as an average daily intake of greater than three units, or an average weekly intake of greater than 21 units (one unit is equivalent to 1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz) of wine) in the last 6 months prior to screening. Known hypersensitivity to quinolones/fluoroquinolones. History of allergic or other serious adverse reactions to benzodiazepines or lidocaine.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WCK 2349<br>Subjects will receive oral doses of WCK 2349 administered twice-daily for five days starting on Day 1 | Drug: WCK-2349<br>* Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM) | Determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady-state plasma pharmacokinetics of levonadifloxacin | To compare the steady-state plasma pharmacokinetics of levonadifloxacin following administration of WCK 2349 | 5 days | 
| Safety and tolerability parameters-number of adverse event , change in clinical laboratory tests, ECG readings, change in physical examination and vital sign |  | 14 days |