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

Completed · Phase 1 · Has a placebo group

Conditions studied: Antibiotics Causing Adverse Effects in Therapeutic Use

In brief

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.

Key facts

Study ID

NCT03622008

Run by

Wockhardt

People needed

20

Starts

2018-03-23

Expected to finish

2018-05-30

Last updated by the study team

2018-08-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.