Cefazolin PK Study 3g vs 2g

Pharmacokinetic Study of Cefazolin 3 g/150 mL in Subjects Weighing Greater Than or Equal to 120 kg Versus Cefazolin 2 g/100 mL in Subjects Weighing Less Than 120 kg

Study is to characterize the safety and tolerability of cefazolin after a single IV administration in healthy subjects in a 3 g/150 mL presentation to meet the increasing clinical need for the indication of perioperative prophylaxis in this patient population weighing greater than or equal to (≥) 120 kg.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Cefazolin

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Baxter Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject provides informed consent (approved by an Institutional Review Board [IRB]) before any study specific evaluation is performed.
• Subject is between the ages of 18 and 55 years (both inclusive).
• A female subject is eligible to participate if she is not pregnant, breastfeeding, and not planning to become pregnant at Screening and upon Admission to the clinic.

• Subject must agree to use an adequate method of contraception

  • For male subjects: Subjects willing to follow approved birth control methods (a double barrier method) from signed ICF to Follow up call as judged by the Investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence. Subjects should also not donate sperm during this time.
  • For female subjects: Female subjects of childbearing potential, defined as a woman ≤ 55 years of age who has not had a partial or full hysterectomy or oophorectomy, must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at Screening and Admission. Subjects of childbearing potential must use a medically acceptable means of contraception from signed ICF to Follow up call. Subjects should also not participate in egg donation during this time.
• Subject must, in the opinion of the Investigator, be in good health based upon medical history, physical examination (including vital signs) and clinical laboratory tests assessed at the time of Screening.
• Subject is a nonsmoker or has quit smoking at least 6 months before the dose of study drug.

Exclusion Criteria:

• Subject has a known history of hypersensitivity to cefazolin, any of its components, or any beta lactam antibiotic.
• Subject has active or recurring clinically significant renal, hepatic, skin, head, ears, eyes, nose, throat, respiratory, cardiovascular, gastrointestinal, endocrine/metabolic, genitourinary, neurologic, hematologic, musculoskeletal, immunologic, allergic, psychological/psychiatric, or other disease requiring medical treatment.
• Subject has an active malignancy of any type other than nonmelanomatous skin malignancies.
• Subject has any history of alcohol abuse or drug addiction.
• Subject has a positive test result for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, oxycodone), cotinine, or alcohol.
• Subject has any history of relevant drug and/or food allergies as judged by the Investigator.
• Subjects who have received any IMP in a clinical research study within 5 halflives or within 30 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days.
• Subject has received probenecid within 4 weeks before dosing, or any other overthe-counter medication (including vitamins, herbal supplements, or dietary supplements) within 2 weeks before dosing.
• Subject has donated or lost 550 mL or more of blood (including plasmapheresis) within 60 days before the first dose of study drug.
• Subject has a positive test result for human immunodeficiency virus (HIV; 1 or 2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody.
• Subject has any clinically significant illness within 5 days before the first dose of study drug as judged by the Investigator.
• Subject is a member of the professional or ancillary personnel involved in the study.
• Subject is deemed not suitable for entry into the study in the opinion of the Investigator.
• Failed facility's COVID-19 screening questions or tested positive for COVID-19 in a polymerase chain reaction (PCR) test on Study Day.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 g cefazolin; Healthy adult subjects weighing ≥120 kg. (g=grams)	Drug: Cefazolin; Cefazolin Injection - 2 g/100 mL or 3 g/150 mL
Active Comparator: 2 g cefazolin; Healthy adult subjects weighing <120 kg. (g=grams)	Drug: Cefazolin; Cefazolin Injection - 2 g/100 mL or 3 g/150 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (AUC)	Cefazolin in plasma.	Day 1 (15 minutes prior to dosing as a baseline measurement and at 2, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300,360, 420, and 480 minutes post-dosing)
Maximum concentration (Cmax)	Cefazolin in plasma	Day 1 (15 minutes prior to dosing as a baseline measurement and at 2, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300,360, 420, and 480 minutes post-dosing)
Number of subjects with TEAEs	Treatment Emergent Adverse Events (TEAEs)	Day 1 to Day 10
Number of subjects with Non-serious TEAEs		Day 1 to Day 10
Number of subjects with Serious TEAEs		Day 1 to Day 10
Number of subjects with TEAEs related to study treatment		Day 1 to Day 10
Number of subjects with Serious TEAEs related to study treatment		Day 1 to Day 10
Number of subjects with TEAEs leading to withdrawal		Day 1 to Day 10
Number of subjects with phlebitis at the infusion site		Day 1 to Day 10

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: BXU567633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
• IPD Sharing Time Frame: Upon approval of a legitimate research request.
• IPD Sharing Access Criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes