Pharmacokinetics of WCK 2349 In Patients With Hepatic Imp... | NCT02244827

NCT02244827

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Label	Type	Description	Intervention Names
WCK 2349	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
WCK 2349	Drug	levonadifloxacin (active drug) and the sulfate metabolite	WCK 2349

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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:

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.