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

Phase 1

Completed

• Conditions: Serious Gram-negative Infections
• Interventions: Drug: Placebo; Drug: Intravenous infusions of WCK 5222

• Registration Number: NCT02707107
• Lead Sponsor: Wockhardt

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-15
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-14
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	administered as IV infusions every q8h, over a period of 60 minutes.
3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6	Intravenous infusions of WCK 5222	administered as IV infusions every q8h, over a period of 60 minutes.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment	14 days

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration	7 days
Time to Cmax	7 days

Trial Locations

Locations (1)

Quintiles; 🇺🇸 Overland Park, Kansas, United States