NCT02253342 is a Phase 1 clinical trial of WCK-2349 in Intrapulmonary Pharmacokinetics of WCK 2349, sponsored by Wockhardt.

Who is sponsoring NCT02253342?

NCT02253342 is sponsored by Wockhardt.

What drugs are being tested in NCT02253342?

Interventions in NCT02253342: WCK-2349.

What condition does NCT02253342 study?

NCT02253342 studies Intrapulmonary Pharmacokinetics of WCK 2349.

Is NCT02253342 still recruiting?

NCT02253342 is currently completed. Last updated 28 October 2015.

Last reviewed 2015-10-28 · How we verify

NCT02253342

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

A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects

Completed Phase 1 Last updated 28 October 2015

What this trial tests

Phase 1 trial testing WCK-2349 in Intrapulmonary Pharmacokinetics of WCK 2349 in 30 participants. Completed in 1 August 2015.

Timeline

1 September 2014

Primary endpoint
1 December 2014

1 August 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	30
Start date	1 September 2014
Primary completion	1 December 2014
Estimated completion	1 August 2015
Sites	1 location across United States

Drugs / interventions tested

WCK-2349 — full drug profile →

Conditions studied

Intrapulmonary Pharmacokinetics of WCK 2349 — all drugs for Intrapulmonary Pharmacokinetics of WCK 2349 →

Sponsor

Wockhardt — full company profile →

Who can join

Adults 18 to 55, any sex, with Intrapulmonary Pharmacokinetics of WCK 2349. Healthy volunteers can join.

What's being measured

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

Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM)
Time frame: 5 days
Determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349

Sponsor's own description

This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in healthy adult subjects.

Publications & conference data

4 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
Intrapulmonary Pharmacokinetics of Levonadifloxacin following Oral Administration of Alalevonadifloxacin to Healthy Adult Subjects.
Rodvold KA, Gotfried MH, Chugh R, Gupta M, et al · · 2018 · cited 23× · PMID 29263070 · DOI 10.1128/aac.02297-17
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 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 NCT02253342 (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/NCT02253342.

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