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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02244827
Other study ID # W-2349-102
Secondary ID
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


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
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