To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)

Study Overview
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Brief Summary
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To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult volunteers for 10 days.

Official Title
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A Phase 1, Randomized, Double-Blind Study to Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) After Intravenous Administrations in Healthy Volunteers

Conditions
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Antibiotics Causing Adverse Effects in Therapeutic Use

Intervention / Treatment
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* Drug: FEP-TAZ 4 g
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a body Mass Index (BMI) between 18 to 32 kg/m2 (both inclusive). Medical history without any major pathology. A sustained supine systolic blood pressure <150 mm Hg or >90 mm Hg or a supine diastolic blood pressure <95 mm Hg or >50 mm Hg at Screening or Check-in (Day -1). Blood pressure may be retested once in the supine position. Glomerular filtration rate (GFR) > 80 mL/min, estimated by the Cockcroft-Gault equation. Exclusion Criteria: Use of cefepime and/or tazobactam within 60 days prior to study drug administration. History or evidence of clinically relevant pathology which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will receive one of the following IV treatments as a q8h infusion (90 min) regimen for 10 days: FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) (n=16) Placebo (n=4)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FEP-TAZ 4 g<br>FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days | Drug: FEP-TAZ 4 g<br>* FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days<br>|
| Placebo Comparator: Placebo<br>placebo IV | Other: Placebo<br>* Placebo IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by number of abnormal clinical laboratory test result |  | every 8 hours | 
| To measure the Maximum Concentration |  | 24 hrs | 
| To measure the Area Under the Curve [AUC] |  | 24 hrs | 
| Safety assessed by number of abnormal physical examinations findings. |  | every 8 hours | 
| Safety assessed by number of abnormal vital signs findings |  | every 8 hours | 
| Safety assessed by number of abnormal 12 Lead ECG findings |  | every 8 hours |