Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX

Completed · Phase 1

Conditions studied: Infection

In brief

The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin 1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult subjects for 11 days of administration.

Key facts

Study ID

NCT01121354

Run by

B. Braun Medical Inc.

People needed

24

Starts

2009-12-01

Expected to finish

2010-02-01

Last updated by the study team

2013-07-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy subjects, male and female
• Age: 18 - 70 years (inclusive) at the time of screening.
• Females of non-child bearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal >= 1 year with follicle stimulating hormone [FSH] > 40 U/L).
• Healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory evaluations).
• Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent and the Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to performing any of the screening procedures.

You may not qualify if…

• Known allergy or hypersensitivity to beta-lactam/cephalosporin antibiotics, corn products or any of the other ingredients of the Investigational Products
• Subjects with impaired renal function based on the Cockcroft-Gault formula using actual body weight, i.e. estimated creatinine clearance <= 80 mL/min (performed at Screening only)
• Body Mass Index (BMI) < 20.0 or > 30.0 kg/m\^2
• Body Weight < 50.0 kg
• White Blood Count (WBC) < 3.5 x10\^3/uL or > ULN
• absolute neutrophil count (ANC) < 1.5 x10\^3/uL or > ULN
• Alarine aminotransferase and aspartate aminotransferase > upper limit of normal
• Other laboratory tests that are outside the normal limits, considered by the investigator, to be clinically significant.
• Use of any medication on a chronic basis.
• Takes any medication which interferes with the study drug or study procedures including aminoglycosides, anticoagulants, and probenecids.
• Use of over the counter (OTC) medications (including vitamins), prescription medications, or herbal remedies from 14 days prior to Day -1 until end of study. By exception, acetaminophen <= 1 gram per day is permitted.
• Tobacco use during the last 2 months prior to enrollment.
• Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
• Positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) at Screening or Day -1
• Positive blood test for ethanol at screening or Day -1.
• At screening, the subject has a clinically relevant ECG change, as assessed by the PI or designee.
• Concurrent acute or chronic infections (e.g. viral infections, except chronic recurrent herpes infections)
• History of or ongoing alcohol abuse or drug abuse (within last 2 years).
• Received an Investigational drug or device within 30 days of first dose of study drug
• Clinically relevant medical conditions which are likely to interfere with the evaluation of the trial drug, e.g. COPD, metabolic disorders (such as clinical and sub-clinical diabetes mellitus), history of malignant diseases (within last 5 years), autoimmune diseases, and cardiovascular disease
• Any planned medical intervention or personal event that might interfere with the ability to comply with the study requirements
• Any condition that, in the opinion of the principal investigator, would compromise the safety of the patient or the quality of the data
• Unable or unwilling to adhere to the study-specified procedures and restrictions

Where it is running

• PAREXEL Early Phase Clinical Unit — Baltimore, Maryland, 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.