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OpenTrials
Completed

NCT Number: NCT03630094

Plasma and Intrapulmonary Concentrations Study of WCK 5222

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

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Key information

Conditions

PHA1A

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FEP-ZID

Drug

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

Primary outcomes

  1. concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)

    Time frame: Day 3

  2. concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM)

    Time frame: Day 3

Secondary outcomes

  1. Number of adverse event reported

    Time frame: Day 3

  2. number variation noted in 12-lead electrocardiogram

    Time frame: Day 3

Sponsors and collaborators

Lead sponsor

Wockhardt

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2018
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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