Cefazolin PK Study 3g vs 2g

NCT05309304 | Completed Phase 1 FDA Drug

• 1 other identifier: BXU567633
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

3 g cefazolin

EXPERIMENTAL

Healthy adult subjects weighing ≥120 kg. (g=grams)

Drug: Cefazolin

2 g cefazolin

ACTIVE COMPARATOR

Healthy adult subjects weighing \<120 kg. (g=grams)

Drug: Cefazolin

Interventions

Cefazolin DRUG

Cefazolin Injection - 2 g/100 mL or 3 g/150 mL

2 g cefazolin; 3 g cefazolin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (1)

Baxter Investigational Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: February 14, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon approval of a legitimate research request.
• 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.

Locations

US (1)