MED Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Volunteers

August 3, 2016 updated by: Wockhardt

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Adult Human Subjects

Study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses of intravenous WCK 5222 (Zidebactam and Cefepime) in healthy adult human subjects.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Quintiles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height(m2).
  2. Resting supine blood pressure of 90 to 139 (systolic)/40 to 89 (diastolic) mmHg and a resting pulse rate of 40 to 100 beats per minute.
  3. Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
  4. All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.

Exclusion Criteria:

  1. Participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before investigational product administration in this study.
  2. History/evidence of clinically relevant pathology related to the cardiovascular system, central nervous system, respiratory tract, gastrointestinal tract, endocrinology, immunology, hematology or any other systemic disorder/major surgeries, that in the opinion of the Principal Investigator would confound the subject's participation and follow-up in the study.
  3. History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
  4. History of Clostridium difficile induced diarrhea or infection within 1 year before screening.
  5. Prior exposure to zidebactam.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6
administered as IV infusions every q8h, over a period of 60 minutes.
Placebo Comparator: Placebo
administered as IV infusions every q8h, over a period of 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum plasma concentration
Time Frame: 7 days
7 days
Time to Cmax
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • W-5222-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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