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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2018-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

NCT03630081

Complicated Urinary Tract Infection Acute Pyelonephritis

NOT_YET_RECRUITING PHASE3

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime

NCT02532140

Healthy

COMPLETED PHASE1

Plasma and Intrapulmonary Concentrations Study of WCK 5222

NCT03630094

PHA1A

COMPLETED PHASE1

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

NCT02707107

Serious Gram-negative Infections

COMPLETED PHASE1

Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)

NCT02070757

Healthcare-Associated Pneumonia Ventilator-Associated Pneumonia Lung Diseases

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antibiotics Causing Adverse Effects in Therapeutic Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double-blind study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

FEP-TAZ 4 g

Intervention Type DRUG

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

Placebo

placebo IV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Placebo

Placebo IV

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes