Overview

Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Wockhardt
Treatments:
Levonadifloxacin
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:

- 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.