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Ceftibuten

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 21, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

Ceftibuten · 1 trial · 1 indication

Phase 1 1
NCT06593054To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy AdultsHealthy
COMPLETED13 Analytics
PHASE1COMPLETED
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
Healthy
NCT0659305413
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Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration [Cmax] of cis-CTB and AVI following test formulation administration in fasted or fed state
Through 48 hours in period 1, 2, 3

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

Dose-normalized Maximum Observed Plasma Concentration [Cmax(dn)] of cis-CTB and AVI following test/ reference formulation administration
Through 48 hours in period 1, 2, 3

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

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
Through 48 hours in period 1, 2, 3

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

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
Through 48 hours in period 1, 2, 3

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

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
Through 48 hours in period 1, 2, 3

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.

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
Through 48 hours in period 1, 2, 3

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

Secondary Endpoints

Number of participants with Treatment Emergent Adverse Events (TEAE)
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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CTB-AVP Capsules, fastedEXPERIMENTALReference formulation of CTB-AVP in capsules, administered under fasted conditions
CTB-AVP Tablet , fastedEXPERIMENTALTest formulation of CTB-AVP in tablets, administered under fasted conditions
CTB-AVP Tablet , fedEXPERIMENTALTest formulation of CTB-AVP in tablets, administered under fed conditions

Interventions

NameTypeDescription
CeftibutenDRUGCeftibuten dihydrate, formulated in capsules
Avibactam prodrugDRUGAvibactam prodrug, formulated in capsules
CTB-AVP in TabletDRUGceftibuten and avibactam prodrug, in Tablet formulation
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. 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 ...

Countries:Belgium
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Frequently asked questions about Ceftibuten

What is Ceftibuten used for?

Ceftibuten is an investigational small molecule being studied in healthy adults. It is being evaluated in a Phase 1 clinical trial to understand how different forms of the study medicine are taken up into the blood and the effect of food on the study medicine. It is not approved for any disease or condition.

Who makes Ceftibuten?

Ceftibuten is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting a Phase 1 clinical trial of the drug in healthy volunteers.

What phase is Ceftibuten in?

Ceftibuten is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is completed, and the drug is still in the early stages of clinical research.

What clinical trials is Ceftibuten in?

Ceftibuten is associated with one completed Phase 1 clinical trial, NCT06593054, titled "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." The trial enrolled 13 participants in Belgium and was a controlled, randomized study.

Is Ceftibuten FDA approved?

Ceftibuten is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial in healthy adults was designed to assess how the drug is absorbed into the blood and the impact of food, but it has not been evaluated for safety and efficacy in treating any disease.