Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

Study Overview
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Brief Summary
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This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment and healthy volunteers.

Official Title
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A Phase I, Open Label, Single Dose Study to Evaluate The Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: WCK 2349


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI): 18.0 - 38.0 (Body weight in kg / Height in m2), both inclusive. Subjects must fulfill the following criteria: Patients with hepatic impairment: Considered clinically stable in the opinion of the Investigator Patients with different degrees of impaired hepatic function as assessed by a Child-Pugh classification score: mild (5-6 points), moderate (7-9 points) and severe (10-15 points) impaired hepatic function. Documented history of cirrhosis diagnosed by liver biopsy, ultrasonography (USG), computed tomography (CT) scan, or magnetic resonance imaging (MRI) OR Healthy volunteers: Have normal hepatic function Participants with a history of self-limited hepatitis A with complete resolution documented at least 6 months prior to entry will be allowed Exclusion Criteria: Known hypersensitivity to quinolones/fluoroquinolones. Subjects must not fulfill the following criteria: In hepatically impaired patients: Use of prohibited concomitant medication, with the exception of those essential for the management of hepatic impairment and the treatment of concomitant stable medical conditions for the hepatically impaired patients as per the discretion of the Investigator. Fluctuating or rapidly deteriorating hepatic function as indicated by recent history or widely varying or worsening of clinical and/or laboratory signs of hepatic impairment as judged by the Investigator. Concomitant treatment with Interferon or other prohibited medications Active stage 3 and stage 4 encephalopathy OR Healthy Volunteers: Use of any concomitant medication within 7 days from the screening except those deemed safe for the study by the Investigator and Medical Monitor. History of any clinically significant chronic and/or active hepatic disease including elevations of serum transaminases including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) [except those which are considered non-significant by the Investigator; however, these should not exceed 1.5 times the Upper Limit of Normal (ULN)], hepatitis (Hepatitis A, B or C), biliary tract disease, or history of any significant gastrointestinal surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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>Each subject will receive a single oral dose of WCK 2349 1000 mg (i.e., 2 tablets of 400 mg and 1 tablet of 200 mg) with 240 mL water on Day 1 in the morning. Study drug will be administered after a fast of at least 8 hours. | Drug: WCK 2349<br>* levonadifloxacin (active drug) and the sulfate metabolite<br>* Other names: levonadifloxacin (active drug);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the pharmacokinetics parameters -AUC,Cmax, tmax, λz, t1/2, systemic clearance and apparent volume of distribution. | To compare the pharmacokinetics of levonadifloxacin and its sulfate metabolite after a single dose of oral WCK 2349 in patients with hepatic impairment and healthy volunteers | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability parameters- Number of AE , Vital signs, clinical laboratory values, abnormal physical examinations and ECGs | To evaluate the safety and tolerability of oral WCK 2349 in patients with hepatic impairment and healthy volunteers | 7 weeks |