Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: WCK 2349

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami,Division of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WCK 2349; 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; levonadifloxacin (active drug) and the sulfate metabolite; Other Names: levonadifloxacin (active drug)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wockhardt
• Investigators: Principal Investigator: Richard A Preston, M.D., Division of Clinical Pharmacology,University of Miami

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 28, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Levonadifloxacin
• Other Study ID Numbers: W-2349-102