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

Wockhardt

Status and phase: Completed; Phase 1

Conditions: Antibiotics Causing Adverse Effects in Therapeutic Use

Treatments: Drug: FEP-TAZ 4 g; Other: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03622008

W-4282-105

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

FEP-TAZ 4 g

Experimental group

Description:

FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days

Treatment:

Drug: FEP-TAZ 4 g

Placebo

Placebo Comparator group

Description:

placebo IV

Treatment:

Other: Placebo