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

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

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.

Study Overview

• Status: Completed
• Conditions: Antibiotics Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Other: Placebo; Drug: FEP-TAZ 4 g

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • West Bend, Wisconsin, United States, 53095
      • Spaulding Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wockhardt
• Collaborators: Clinartis, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2018
• Primary Completion (Actual): May 13, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: July 15, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: W-4282-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No