Plasma and Intrapulmonary Concentrations Study of WCK 5222

PHA1A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630094
• Other study ID #: W-5222-104
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2017
• Est. completion date: July 30, 2017

Study information

• Verified date: August 2018
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• PHA1A

Intervention

Drug:
• FEP-ZID
A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen

Locations

Country	Name	City	State
United States	Pulmonary Associates	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Wockhardt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)		Day 3
Primary	concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM)		Day 3
Secondary	Number of adverse event reported		Day 3
Secondary	number variation noted in 12-lead electrocardiogram		Day 3