Clincosm LogoSign in Get a demo

MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults

Sponsor
Wockhardt (Industry)
Overall Status
Completed
CT.gov ID
NCT02674347
Collaborator
Quintiles, Inc. (Industry)
21
Enrollment
1
Location
2
Arms
2
Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) Zidebactam in healthy adult human subjects.

Condition or Disease Intervention/Treatment Phase
  • Drug: 3 g or 6 g Zidebactam
  • Drug: Placebo
 Phase 1

Detailed Description

A double-blind, placebo-controlled study where healthy adult subjects will be randomly assigned to receive either of the investigational products (Zidebactam or placebo) in 2 multiple ascending dose (MAD) cohorts.

Primary Objective: to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) zidebactam in healthy adult human subjects.

Secondary Objective: to evaluate the pharmacokinetics (PK) of multiple escalating doses of IV zidebactam in healthy adult human subjects.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous Zidebactam in Healthy Adult Human Subjects
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: 3 g or 6 g of Zidebactam

Cohort 1 (Zidebactam): 3 g of Zidebactam (1 g every 8 hours [q8h]) (n=8) IV infusions administered over 60 minutes. Cohort 2 (Zidebactam or placebo): 6 g of Zidebactam (2 g q8h) (n=8) IV infusions administered over 60 minutes.

Drug: 3 g or 6 g Zidebactam
IV for over a duration of 60 minutes
Other Names:
  • WCK 5107

    		•
    Placebo Comparator: Placebo

    Cohort 1: Placebo every 8 hours [q8h] (n=2) IV infusions administered over 60 minutes. Cohort 2: Placebo every q8h (n=2) IV infusions administered over 60 minutes.

    Drug: Placebo
    IV matching the Investigational drug

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability will be evaluated by reported AEs, clinical observations, vital signs measurements, and physical examination findings. [14 days]

    2. Safety and tolerability will be evaluated by 12-lead safety ECG results and clinical laboratory test results [14 days]

    Secondary Outcome Measures

    1. Pharmacokinetic parameters -maximum plasma concentration will be evaluated. [7 days]

    2. Pharmacokinetic parameters- area under the plasma concentration-time curve from zero (pre-dose) to 8 hours will be evaluated. [7 days]

    3. Pharmacokinetic parameters- terminal half life etc will be evaluated [7 days]

    Eligibility Criteria

    Criteria

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

    1. Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).

    2. Medical history without any major pathology/surgery in the last 6 months prior to screening.

    3. All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.

    4. 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.

    5. Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).

    6. Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.

    Exclusion Criteria:

    1. History of clinically significant food or drug allergy, including known hypersensitivity to β lactam drugs or other related drugs.

    2. History of Clostridium difficile induced diarrhea or infection within 1 year before screening

    3. Consumed more than 28 units of alcohol per week at any time in the 6 months before investigational product administration

    4. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Quintiles Overland Park Kansas United States 66211

    Sponsors and Collaborators

    • Wockhardt
    • Quintiles, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wockhardt
    ClinicalTrials.gov Identifier:
    NCT02674347
    Other Study ID Numbers:
    • W-5107-102
    First Posted:
    Feb 4, 2016
    Last Update Posted:
    Aug 4, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Aug 4, 2016