Plasma and Intrapulmonary Concentrations Study of WCK 5222

Phase 1

Completed

• Conditions: PHA1A
• Interventions: Drug: FEP-ZID

• 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

Study Timeline

• Study First Submitted: 2017-03-17
• Study Start: 2017-03-31
• Primary Completion: 2017-06-30
• Study Completion: 2017-07-30
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-14
• Last Update Posted: 2018-08-14

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