Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ceftibuten · 1 trial · 1 indication
Cmax is estimated based on the plasma concentrations for test and reference formulation
Cmax is estimated based on the plasma concentrations for test and reference formulation and then normalized by dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) normalized by dose
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.
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
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Ceftibuten | DRUG | Ceftibuten dihydrate, formulated in capsules |
| Avibactam prodrug | DRUG | Avibactam prodrug, formulated in capsules |
| CTB-AVP in Tablet | DRUG | ceftibuten and avibactam prodrug, in Tablet formulation |
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 ...
Ceftibuten is a small molecule drug being developed by Pfizer, Inc. (ticker PFE). It is in Phase 1 clinical development. The therapeutic area and specific indications for ceftibuten have not been publicly disclosed.
Ceftibuten is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating ceftibuten.
Ceftibuten is in Phase 1 clinical development. It is an investigational drug and is not approved. One Phase 1 trial of ceftibuten has been completed, and no trials are currently active.
Ceftibuten has been studied in one completed Phase 1 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 healthy adult volunteers in Belgium and was randomized and controlled.
The completed Phase 1 trial of ceftibuten, NCT06593054, enrolled 13 healthy adult volunteers of all sexes, aged 18 years and older, in Belgium. It was a randomized, controlled study that was not double blind and did not use biomarker selection.