HealthyPhase 1NCT05309304
Cefazolin PK Study 3g vs 2g
A Phase 1 study testing Cefazolin in people with Healthy, run by Baxter Healthcare Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cefazolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 30 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baxter Investigational Site
Baltimore, Maryland, 21225
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Cefazolin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Cefazolin Injection - 2 g/100 mL or 3 g/150 mL
| Study group | Role | What they receive |
|---|---|---|
| 3 g cefazolin | Experimental | Healthy adult subjects weighing ≥120 kg. (g=grams) Receives: Drug: Cefazolin |
| 2 g cefazolin | Active comparator | Healthy adult subjects weighing <120 kg. (g=grams) Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
Cefazolin in plasma.
Measured: 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
Measured: 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)
Measured: Day 1 to Day 10
Number of subjects with Non-serious TEAEs
Measured: Day 1 to Day 10
Number of subjects with Serious TEAEs
Measured: Day 1 to Day 10
Number of subjects with TEAEs related to study treatment
Measured: Day 1 to Day 10
Number of subjects with Serious TEAEs related to study treatment
Measured: Day 1 to Day 10
Number of subjects with TEAEs leading to withdrawal
Measured: Day 1 to Day 10
Number of subjects with phlebitis at the infusion site
Measured: Day 1 to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start14 Feb 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309304
- Sponsor's protocol ID
- BXU567633
- Status last verified
- Oct 2022
- First submitted
- 25 Mar 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05309304
- Acronym / sponsor ID
- BXU567633
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 g cefazolin | Experimental | Drug: CefazolinHealthy adult subjects weighing ≥120 kg. (g=grams) |
| 2 g cefazolin | Active comparator | Drug: CefazolinHealthy adult subjects weighing <120 kg. (g=grams) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefazolinCefazolin Injection - 2 g/100 mL or 3 g/150 mL | Drug | 2 g cefazolin, 3 g cefazolin |
Primary outcome
Area under the curve (AUC)
Time frame: 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)
Cefazolin in plasma.
Maximum concentration (Cmax)
Time frame: 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)
Cefazolin in plasma
Number of subjects with TEAEs
Time frame: Day 1 to Day 10
Treatment Emergent Adverse Events (TEAEs)
Number of subjects with Non-serious TEAEs
Time frame: Day 1 to Day 10
Number of subjects with Serious TEAEs
Time frame: Day 1 to Day 10
Number of subjects with TEAEs related to study treatment
Time frame: Day 1 to Day 10
Number of subjects with Serious TEAEs related to study treatment
Time frame: Day 1 to Day 10
Number of subjects with TEAEs leading to withdrawal
Time frame: Day 1 to Day 10
Number of subjects with phlebitis at the infusion site
Time frame: Day 1 to Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cefazolin in people with Healthy, run by Baxter Healthcare Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) (time frame: 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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.