Plasma and Intrapulmonary Concentrations Study of WCK 5222

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

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

Study Overview

• Status: Completed
• Conditions: PHA1A
• Intervention / Treatment: Drug: FEP-ZID

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Pulmonary Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FEP-ZID via intravenous; total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen	Drug: FEP-ZID; A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of adverse event reported	Day 3
number variation noted in 12-lead electrocardiogram	Day 3

Collaborators and Investigators

• Sponsor: Wockhardt

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: W-5222-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No