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Ceftibuten

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06593054To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy AdultsPHASE1 COMPLETED 13 — — Jul 29, 2024Oct 11, 2024May 21, 20251 Belgium
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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 — 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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