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

NCT02707107 | Completed Phase 1

• 1 other identifier: W-5222-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Serious Gram-negative Infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  14 days

Secondary Outcomes (2)

• Maximum plasma concentration

  7 days

• Time to Cmax

  7 days

Study Arms (2)

3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6

ACTIVE COMPARATOR

administered as IV infusions every q8h, over a period of 60 minutes.

Drug: Intravenous infusions of WCK 5222

Placebo

PLACEBO COMPARATOR

administered as IV infusions every q8h, over a period of 60 minutes.

Drug: Placebo

Interventions

Intravenous infusions of WCK 5222 DRUG

3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height(m2).
• 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.
• Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
• All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.

You may not qualify if:

• 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.
• 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.
• History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
• History of Clostridium difficile induced diarrhea or infection within 1 year before screening.
• Prior exposure to zidebactam.

Sponsors & Collaborators

• Wockhardt: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Quintiles

Overland Park, Kansas, 66211, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: March 14, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 4, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)