Clinical trial NCT02244827: Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment
Official title: A Phase I, Open Label, Single Dose Study to Evaluate The Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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:

* 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.

Primary outcomes:
measure: To compare the pharmacokinetics parameters -AUC,Cmax, tmax, λz, t1/2, systemic clearance and apparent volume of distribution.
timeFrame: 48 hours
Secondary outcomes:
measure: To evaluate the safety and tolerability parameters- Number of AE , Vital signs, clinical laboratory values, abnormal physical examinations and ECGs
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami,Division of Clinical Pharmacology
state: Florida
Study officials:
affiliation: Division of Clinical Pharmacology,University of Miami
name: Richard A Preston, M.D.
role: PRINCIPAL_INVESTIGATOR
References: