A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 5222 (Cefepime and Zidebactam) in Healthy Adult Human Subjects

Wockhardt1 site in 1 country36 target enrollmentMarch 31, 2017

ConditionsPHA1A

InterventionsFEP-ZID

Overview

Phase: Phase 1
Intervention: FEP-ZID
Conditions: PHA1A
Sponsor: Wockhardt
Enrollment: 36
Locations: 1
Primary Endpoint: concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)
Status: Completed
Last Updated: 7 years ago

This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.

Registry

clinicaltrials.gov

Start Date

March 31, 2017

End Date

July 30, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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.