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

Phase 1

Completed

• Conditions: Antibiotics Causing Adverse Effects in Therapeutic Use
• Interventions: Other: Placebo; Drug: FEP-TAZ 4 g

• Registration Number: NCT03622008
• Lead Sponsor: Wockhardt

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-23
• Primary Completion: 2018-05-13
• Study Completion: 2018-05-30
• Study First Submitted: 2018-07-15
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-03
• Last Update Submitted: 2018-08-08
• Study First Posted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo IV
FEP-TAZ 4 g	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

Primary Outcome Measures

Name	Time	Method
Safety assessed by number of abnormal 12 Lead ECG findings	every 8 hours
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 clinical laboratory test result	every 8 hours
Safety assessed by number of abnormal vital signs findings	every 8 hours
To measure the Maximum Concentration	24 hrs

Trial Locations

Locations (1)

Spaulding Clinical Research; 🇺🇸 West Bend, Wisconsin, United States