AzTrials
AzTrials

HealthyPhase 1NCT06593054

To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy Adults

A Phase 1 study testing Ceftibuten, Avibactam prodrug and CTB-AVP in Tablet in people with Healthy, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to learn about the study medicine CTB-AVP for the treatment of severe urinary tract infections that require hospitalization. This study is seeking for: adult male and female participants who are healthy and weigh more than 50 kg. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ceftibuten, Avibactam prodrug and CTB-AVP in Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteBelgium
Study dates
29 Jul 2024to 11 Oct 2024
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female participants aged 18 years or older at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and standard 12-lead electrocardiogram (ECGs), and with eGFR ≥75 mL/min (estimated using the 2021 CKD-EPI equation).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Have a body-mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg (110 lb).
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease; including any condition affecting oral absorption or known allergy to cephalosporin group of antibiotics
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention or current use of any prohibited concomitant medications.
  • Screening supine Blood Pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm Hg for participants ≥60 years old, following at least 5 minutes of supine rest
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: alanine aminotransferase (ALT), aspartate aminotransferase (AST), Bilirubin ≥1.5 x Upper Limit of Normal (ULN). Participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Pfizer Clinical Research Unit - Brussels

    Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

Official title: An Interventional Open-Label, Single-Dose, 4-Treatment, 4-Period Crossover Study to Evaluate the Relative Bioavailability of CTB and AVI Administered Via Various Tablets or Capsule Formulations of PF-07612577 (PF-06264006 [CTB] - PF-07338233 [AVP]) and the Effect of Food on the Bioavailability of CTB and AVI Administered Via Tablets in Healthy Adult Participants

The purpose of this study is to learn about the study medicine CTB-AVP for the treatment of severe urinary tract infections that require hospitalization.

This study is seeking for:

Read more
  • adult male and female participants who are healthy and weigh more than 50 kg.
  • participants who have normal blood pressure, normal kidney and liver function
  • participants willing to stay away from caffeine and other medicines for the duration of the study.

Participants will be required to stay in the study clinic for two weeks. All participants in this study will receive study medicine CTB-AVP by mouth one time each day on four different days. Study medicine will be given in capsules or tablets, on an empty stomach or will be taken with a meal. The study will look at the experiences of people receiving the study medicine. This will help determine if the study medicine is safe and effective.

Conditions
Healthy
Being tested
Ceftibuten, Avibactam prodrug, CTB-AVP in Tablet
Keywords
ceftibuten, avibactam prodrug, relative bioavailability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CeftibutenDrug

    Ceftibuten dihydrate, formulated in capsules

  • Avibactam prodrugDrug

    Avibactam prodrug, formulated in capsules

  • CTB-AVP in TabletDrug

    ceftibuten and avibactam prodrug, in Tablet formulation

Study groups in NCT06593054
Study groupRoleWhat they receive
CTB-AVP Capsules, fastedExperimentalReference formulation of CTB-AVP in capsules, administered under fasted conditions
Receives: Drug: Ceftibuten; Drug: Avibactam prodrug
CTB-AVP Tablet , fastedExperimentalTest formulation of CTB-AVP in tablets, administered under fasted conditions
Receives: Drug: CTB-AVP in Tablet
CTB-AVP Tablet , fedExperimentalTest formulation of CTB-AVP in tablets, administered under fed conditions
Receives: Drug: CTB-AVP in Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration [Cmax] of cis-CTB and AVI following test formulation administration in fasted or fed state

    Cmax is estimated based on the plasma concentrations for test and reference formulation

    Measured: Through 48 hours in period 1, 2, 3

  2. Dose-normalized Maximum Observed Plasma Concentration [Cmax(dn)] of cis-CTB and AVI following test/ reference formulation administration

    Cmax is estimated based on the plasma concentrations for test and reference formulation and then normalized by dose

    Measured: Through 48 hours in period 1, 2, 3

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of cis-CTB and AVI following test formulation administration in fasted or fed state

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

    Measured: Through 48 hours in period 1, 2, 3

  4. Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast(dn)] of cis-CTB and AVI following test/ reference formulation administration

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) normalized by dose

    Measured: Through 48 hours in period 1, 2, 3

  5. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of cis-CTB and AVI (if data permit) following test formulation administration in fasted or fed state

    AUC (inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUClast plus AUClast to infinity.

    Measured: Through 48 hours in period 1, 2, 3

  6. Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf(dn)] of cis-CTB and AVI (if data permit) following test/ reference formulation administration

    AUC (inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUClast plus AUClast to infinity normalized by dose

    Measured: Through 48 hours in period 1, 2, 3

Secondary outcomes (14)

  1. Number of participants with Treatment Emergent Adverse Events (TEAE)

    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment

    Measured: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention

  2. Severity of treatment-emergent adverse events (TEAEs)

    Measured: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention

  3. Causal relationship of treatment-emergent adverse events (TEAEs)

    Measured: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention

  4. Withdrawals due to treatment-emergent adverse events (TEAEs)

    Measured: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention

  5. Number of Participants With Laboratory Abnormalities

    Blood samples collected for the analysis of following laboratory parameters: hematology parameters (hemoglobin, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin, erythrocyte mean corpuscular hemoglobin concentration platelet count, leukocytes, lymphocytes, neutrophils, eosinophils, monocytes); clinical chemistry parameters (bilirubin, alanine aminotransferase [ALT], blood urea nitrogen [BUN], creatinine, potassium, bicarbonate); urine parameters: urine protein, urine hemoglobin, nitrite, leukocyte esterase and bacteria. Number of participants with any laboratory abnormalities is presented.

    Measured: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention

  6. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP) and pulse rate. Baseline will be the measurement taken on Day -1 and change from baseline (CFB) will be calculated for all post-baseline timepoints, and would be reported as per Sponsor's reporting standards.

    Measured: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention

  7. Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

    Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥60 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG

    Measured: Time the participant provides informed consent through and including follow-up contact occurring up to 35 days after the last administration of the study intervention

  8. Time to Cmax (Tmax) of cis-CTB, AVI and hydroxypivalic acid (HPA)

    Tmax = time (hours) to maximum plasma concentration (Cmax).

    Measured: Through 48 hours in period 1, 2, 3

  9. Terminal Elimination Half-Life (t1/2) (if data permit) of cis-CTB, AVI and HPA

    Elimination half-life means the time required for the plasma concentration to decline by 50% during the elimination phase- if data permit

    Measured: Through 48 hours in period 1, 2, 3

  10. Apparent Oral Volume of Distribution (Vz/F) (if data permit) of cis-CTB, AVI and HPA

    Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug-If data permit

    Measured: Through 48 hours in period 1, 2, 3

  11. Apparent Oral Clearance (CL/F) (if data permit) of cis-CTB, AVI and HPA

    Clearance of a drug was measure of the rate at which the drug was metabolized or eliminated by normal biological processes- if data permit

    Measured: Through 48 hours in period 1, 2, 3

  12. Dose-Normalized Maximum Observed Plasma Concentration [Cmax(dn)] of HPA

    Measured: Through 48 hours in period 1, 2, 3

  13. Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast(dn)] of HPA

    Measured: Through 48 hours in period 1, 2, 3

  14. Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf(dn)] (if data permit)of HPA

    Measured: Through 48 hours in period 1, 2, 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start29 Jul 2024
  3. Primary completion11 Oct 2024
  4. Study completion11 Oct 2024

Resources

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06593054
Sponsor's protocol ID
C4691003
Other IDs
2023-507117-10-00, 2023
Status last verified
May 2025
First submitted
22 Jul 2024
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Sahasrabudhe SA, Shoji S, Jakate AS, Abraham BK, Toussi SS, Maligalig BJ, Darekar AS, Tripathy S, Kantaridis C, Mfopou JK, Selivanova O, Bergman A, Alami NN, Singh RSP. Dose Selection for Ceftibuten Combined with Avibactam Tomilopil, a Potential Oral Alternative to Carbapenems for Patients with Complicated Urinary Tract Infections. J Clin Pharmacol. 2026 Sep;66(9):e70263. doi: 10.1002/jcph.70263.

    PubMed 42678337

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ceftibuten, Avibactam prodrug and CTB-AVP in Tablet in people with Healthy, run by Pfizer at 1 site in Belgium.

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 4 inclusion and 4 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 21 May 2025. 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 Belgium. 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?

Maximum Observed Plasma Concentration [Cmax] of cis-CTB and AVI following test formulation administration in fasted or fed state (time frame: Through 48 hours in period 1, 2, 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06593054, which also lists 1 linked publication.

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 21 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in