Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment

NCT ID: NCT02244827

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-06-30

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

WCK 2349

Intervention Type: DRUG

levonadifloxacin (active drug) and the sulfate metabolite

Interventions

WCK 2349

levonadifloxacin (active drug) and the sulfate metabolite

Intervention Type: DRUG

Other Intervention Names

levonadifloxacin (active drug)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wockhardt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard A Preston, M.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Clinical Pharmacology,University of Miami

Locations

University of Miami,Division of Clinical Pharmacology

Miami, Florida, United States

Countries

United States

Other Identifiers

W-2349-102

Identifier Type: -

Identifier Source: org_study_id