Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244827
• Other study ID #: W-2349-102
• Status: Completed
• Phase: Phase 1
• First received: September 10, 2014
• Last updated: October 28, 2015
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• WCK 2349
levonadifloxacin (active drug) and the sulfate metabolite

Locations

Country	Name	City	State
United States	University of Miami,Division of Clinical Pharmacology	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Wockhardt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the pharmacokinetics parameters -AUC,Cmax, tmax, ?z, 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	No
Secondary	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	Yes