Trial | NCT02253342  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    wck 2349 ...

  • Study Participants

    30
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.
Study Started
Sep 30
2014
Primary Completion
Dec 31
2014
Study Completion
Aug 31
2015
Last Update
Oct 29
2015
Estimate

Drug WCK-2349

Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1

WCK 2349 Experimental

Subjects will receive oral doses of WCK 2349 administered twice-daily for five days starting on Day 1

Criteria 

Inclusion Criteria:

Healthy adult males or females, 18 to 55 years of age (both inclusive) at the time of screening.
Medical history without any major pathology as judged by the Principal Investigator.

Exclusion Criteria:

History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
Positive urine drug/alcohol testing at screening or confinement.
Positive testing for HIV, Hepatitis B or Hepatitis C.
History or presence of alcohol or drug abuse within the 2 years prior to screening.
Excessive intake of alcohol, defined as an average daily intake of greater than three units, or an average weekly intake of greater than 21 units (one unit is equivalent to 1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz) of wine) in the last 6 months prior to screening.
Known hypersensitivity to quinolones/fluoroquinolones.
History of allergic or other serious adverse reactions to benzodiazepines or lidocaine.
No Results Posted