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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507117-10-00 | Registry Identifier | CTIS (EU) |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTB-AVP Capsules, fasted | Experimental | Reference formulation of CTB-AVP in capsules, administered under fasted conditions |
|
| CTB-AVP Tablet , fasted | Experimental | Test formulation of CTB-AVP in tablets, administered under fasted conditions |
|
| CTB-AVP Tablet , fed | Experimental | Test formulation of CTB-AVP in tablets, administered under fed conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftibuten | Drug | Ceftibuten dihydrate, formulated in capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through 48 hours in period 1, 2, 3 |
| 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 | Through 48 hours in period 1, 2, 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) | Through 48 hours in period 1, 2, 3 |
| 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 | Through 48 hours in period 1, 2, 3 |
| 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. | Through 48 hours in period 1, 2, 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| D000077722 | Ceftibuten |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Avibactam prodrug |
| Drug |
Avibactam prodrug, formulated in capsules |
|
| CTB-AVP in Tablet | Drug | ceftibuten and avibactam prodrug, in Tablet formulation |
|
| 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 |
| Through 48 hours in period 1, 2, 3 |
| 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 |
| Severity of treatment-emergent adverse events (TEAEs) | 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 |
| Causal relationship of treatment-emergent adverse events (TEAEs) | 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 |
| Withdrawals due to treatment-emergent adverse events (TEAEs) | 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 |
| 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. | 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 |
| 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. | 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 |
| 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 | 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 |
| Time to Cmax (Tmax) of cis-CTB, AVI and hydroxypivalic acid (HPA) | Tmax = time (hours) to maximum plasma concentration (Cmax). | Through 48 hours in period 1, 2, 3 |
| 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 | Through 48 hours in period 1, 2, 3 |
| 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 | Through 48 hours in period 1, 2, 3 |
| 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 | Through 48 hours in period 1, 2, 3 |
| Dose-Normalized Maximum Observed Plasma Concentration [Cmax(dn)] of HPA | Through 48 hours in period 1, 2, 3 |
| Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast(dn)] of HPA | Through 48 hours in period 1, 2, 3 |
| Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf(dn)] (if data permit)of HPA | Through 48 hours in period 1, 2, 3 |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |