Plasma and Intrapulmonary Concentrations Study of WCK 5222
- Registration Number
- NCT03630094
- Lead Sponsor
- Wockhardt
- Brief Summary
This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Body mass index (BMI) greater than or equal to18.5 and less than or equal to 30 (kg per m2) and weight between 55.0 and 100.0 kg (both inclusive).
- Medical history without any major pathology as judged by the Investigator.
- Forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at screening.
Exclusion Criteria
- History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal,endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive alcohol breath test or urine drug screen test at screening or confinement.
- Current use or has used tobacco or nicotine containing products 6 month prior to screening.
- Positive testing for HIV, Hepatitis B or Hepatitis C.
- History or presence of alcohol or drug abuse within the 2 years prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FEP-ZID via intravenous FEP-ZID total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen
- Primary Outcome Measures
Name Time Method concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF) Day 3 concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM) Day 3
- Secondary Outcome Measures
Name Time Method Number of adverse event reported Day 3 number variation noted in 12-lead electrocardiogram Day 3
Trial Locations
- Locations (1)
Pulmonary Associates
🇺🇸Phoenix, Arizona, United States