Hepatic Impairment
Conditions
Brief 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.
Interventions
DRUGWCK 2349
levonadifloxacin (active drug) and the sulfate metabolite
Sponsors
Wockhardt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the pharmacokinetics parameters -AUC,Cmax, tmax, λz, t1/2, systemic clearance and apparent volume of distribution. | 48 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability parameters- Number of AE , Vital signs, clinical laboratory values, abnormal physical examinations and ECGs | 7 weeks | To evaluate the safety and tolerability of oral WCK 2349 in patients with hepatic impairment and healthy volunteers |
Countries
United States
Outcome results
None listed