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Plasma and Intrapulmonary Concentrations Study of WCK 5222

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ClinicalTrials.gov Identifier: NCT03630094
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Wockhardt

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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 : March 31, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : July 30, 2017

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of adverse event reported [ Time Frame: Day 3 ]
  2. number variation noted in 12-lead electrocardiogram [ Time Frame: Day 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630094


Locations
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United States, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
Wockhardt

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Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT03630094     History of Changes
Other Study ID Numbers: W-5222-104
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No