NCT01121354

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

2 months

First QC Date

May 10, 2010

Last Update Submit

July 15, 2013

Conditions

Infection

Keywords

CefazolinCaphalosporinantibioticgram positiveInfection control

Outcome Measures

Primary Outcomes (1)

  • To evaluate the pharmacokinetics of an intravenous infusion of Cefazolin 2g in healthy adult subjects at an infusion rate of 50 ml over 15 minutes, and Cefazolin 1.5g in a similar population of healthy adult subjects

    The primary objective is to evaluate the pharmacokinetics of an intravenous infusion of Cefazolin 2g for injection USP and Dextrose injection USP in healthy adult subjects at an infusion rate of 50 ml over 15 minutes, and Cefazolin 1.5g for injection USP and Dextrose injection USP in a similar population of healthy adult subjects.

    PK is evaluated on Days 1 and 11 of infusion therapy

Secondary Outcomes (1)

  • To evaluate the safety of cefazolin 2g injection in total daily doses of 6g over 11 days of administration in healthy volunteers

    Varies, over 11 days of infusion therapy

Study Arms (2)

Cefazolin 2g (Test)

EXPERIMENTAL
Drug: Cefazolin 2g for Injection USP and Dextrose Injection USP

Cefazolin 1.5g (Control)

ACTIVE COMPARATOR
Drug: Cefazolin 1.5g

Interventions

Cefazolin 2g for Injection USP and Dextrose Injection USPDRUG

Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur three times per day (t.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.

Also known as: Cefazolin 2g in DUPLEX (50ml)
Cefazolin 2g (Test)
Cefazolin 1.5gDRUG

Cefazolin 1.5g for Injection USP and Dextrose Injection USP in a pharmacy-prepared container. Administration will occur four times per day (q.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.

Also known as: Cefazolin 1.5g (50ml)
Cefazolin 1.5g (Control)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAREXEL Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Location

Related Publications (6)

  • Abraxis Pharmaceutical Products, Package Insert, Cefazolin for Injection, USP.45858E, July 2006, Schaumburg, IL 60173 (USA).

    BACKGROUND

  • Apotex Corp., Package Insert, Cefazolin for Injection, USP, Pharmacy Bulk Pack. 948025398, December 2005, Weston, FL 33326 (USA).

    BACKGROUND

  • APP Pharmaceuticals, LLC. Package Insert, Cefazolin for Injection, USP. 451180, July 2008, Schaumburg, IL 60173 (USA).

    BACKGROUND

  • Hospira, Inc. Package Insert, Cefazolin for Injection, USP, Pharmacy Bulk Pack. EN-1961/948025777, December 2008, Lake Forest, IL 60045 (USA).

    BACKGROUND

  • B. Braun Medical inc., Package Insert, Cefazolin for Injection USP and Dextrose Injection USP in DUPLEX Container, 1g, Apr 2008, Allentown, PA 18109 (USA).

    BACKGROUND

  • Vella-Brincat JW, Begg EJ, Kirkpatrick CM, Zhang M, Chambers ST, Gallagher K. Protein binding of cefazolin is saturable in vivo both between and within patients. Br J Clin Pharmacol. 2007 Jun;63(6):753-7. doi: 10.1111/j.1365-2125.2006.02827.x. Epub 2007 Jan 12.

    PMID: 17223858BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Azra Hussaini, MD

    Parexel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

December 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations

US(1)