Intrapulmonary Pharmacokinetics of WCK 2349
Conditions
Brief summary
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.
Interventions
DRUGWCK-2349
Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1
Sponsors
Clinartis
Wockhardt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM) | 5 days | Determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Steady-state plasma pharmacokinetics of levonadifloxacin | 5 days | To compare the steady-state plasma pharmacokinetics of levonadifloxacin following administration of WCK 2349 |
| Safety and tolerability parameters-number of adverse event , change in clinical laboratory tests, ECG readings, change in physical examination and vital sign | 14 days | — |
Countries
United States
Outcome results
None listed