Plasma and Intrapulmonary Concentrations Study of WCK 5222

Sponsor

Wockhardt (Industry)

Overall Status

Completed

CT.gov ID

NCT03630094

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
PHA1A	Drug: FEP-ZID	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 31, 2017

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Jul 30, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Number of adverse event reported [Day 3]
number variation noted in 12-lead electrocardiogram [Day 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary Associates	Phoenix	Arizona	United States	85006

Sponsors and Collaborators

Wockhardt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wockhardt

ClinicalTrials.gov Identifier:

NCT03630094

Other Study ID Numbers:

W-5222-104

First Posted:

Aug 14, 2018

Last Update Posted:

Aug 14, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 14, 2018