NCT02244827 is a Phase 1 clinical trial of WCK 2349 in Hepatic Impairment, sponsored by Wockhardt.

Who is sponsoring NCT02244827?

NCT02244827 is sponsored by Wockhardt.

What drugs are being tested in NCT02244827?

Interventions in NCT02244827: WCK 2349.

What condition does NCT02244827 study?

NCT02244827 studies Hepatic Impairment.

Is NCT02244827 still recruiting?

NCT02244827 is currently completed. Last updated 28 October 2015.

Last reviewed 2015-10-28 · How we verify

NCT02244827

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 28 October 2015

What this trial tests

Phase 1 trial testing WCK 2349 in Hepatic Impairment in 48 participants. Completed in 1 June 2015.

Timeline

1 September 2014

Primary endpoint
1 December 2014

1 June 2015

Quick facts

Lead sponsor	Wockhardt
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	48
Start date	1 September 2014
Primary completion	1 December 2014
Estimated completion	1 June 2015
Sites	1 location across United States

Drugs / interventions tested

WCK 2349

Conditions studied

Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

Wockhardt — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Impairment. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To compare the pharmacokinetics parameters -AUC,Cmax, tmax, λz, t1/2, systemic clearance and apparent volume of distribution.
Time frame: 48 hours
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

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Levonadifloxacin, a Novel Broad-Spectrum Anti-MRSA Benzoquinolizine Quinolone Agent: Review of Current Evidence.
Bhagwat SS, Nandanwar M, Kansagara A, Patel A, et al · · 2019 · cited 37× · PMID 31920285 · DOI 10.2147/dddt.s229882
Emerging Treatment Options for Infections by Multidrug-Resistant Gram-Positive Microorganisms.
Koulenti D, Xu E, Song A, Sum Mok IY, et al · · 2020 · cited 27× · PMID 32019171 · DOI 10.3390/microorganisms8020191
Meeting the Unmet Need in the Management of MDR Gram-Positive Infections with Oral Bactericidal Agent Levonadifloxacin.
Mehta Y, Mishra KC, Paliwal Y, Rangappa P, et al · · 2022 · cited 1× · PMID 36785544 · DOI 10.1155/2022/2668199

Verify or expand the search:

Other recruiting trials for Hepatic Impairment

Currently open trials in the same condition.

NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting

Other Wockhardt trials

Trials by the same sponsor.

NCT06806995 — A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Met · Phase 1 · completed
NCT04979806 — Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) · Phase 3 · completed
NCT03981887 — Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin · Phase 1 · completed
NCT03622008 — To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) · Phase 1 · completed
NCT07247942 — Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion. · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02244827 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wockhardt
Last refreshed: 28 October 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02244827.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing