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Ibuzatrelvir co-process API film coated

Phase 1

Coronavirus Disease 2019 | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Jul 28, 2026

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

Ibuzatrelvir co-process API film coated · 1 trial · 11 indications

Phase 1 1
NCT07552779A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of IbuzatrelvirCoronavirus Disease 2019
COMPLETED17 Analytics
PHASE1COMPLETED
A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of Ibuzatrelvir
Coronavirus Disease 2019Unlock trial analytics

Study Endpoints

Primary Endpoints

Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast) in the fasted state
Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period

Relative bioavailability of a new oral formulation of ibuzatrelvir compared to the original tablet formulation in the fasted state

Plasma ibuzatrelvir Cmax in the fasted state
Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period

Relative bioavailability of a new oral formulation of ibuzatrelvir compared to the original tablet formulation in the fasted state

Secondary Endpoints

Incidence of AEs, clinical laboratory measurements, vital signs, and standard 12-lead ECGs
Day 1-35
Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast)
Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
Plasma ibuzatrelvir Cmax
Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALsingle dose of ibuzatrelvir original tablet formulation in the fasted state on Day 1 of the treatment period
Treatment BEXPERIMENTALsingle dose of ibuzatrelvir new tablet formulation in the fasted state on Day 1 of the treatment period
Treatment CEXPERIMENTALsingle dose of ibuzatrelvir of the new tablet formulation dispersed in water and given in the fasted state on Day 1 of the treatment period
Treatment DEXPERIMENTALsingle dose of ibuzatrelvir new tablet formulation in the fed state on Day 1 of the treatment period

Interventions

NameTypeDescription
Ibuzatrelvir co-process API film coated tabletDRUGoriginal
Ibuzatrelvir filmcoated tabletDRUGnew
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Eligibility Criteria

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

Inclusion criteria: 1. 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. 2. BMI of 16-32 kg/m2; and a tot...

Countries:Belgium
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Recent Changes (Last 90 Days)

MEDIUMAug 28, 2026NCT07552779TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT07552779TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT07552779TRIAL_REMOVED: changed
MEDIUMAug 28, 2026NCT07552779TRIAL_REMOVED: changed
HIGHJul 28, 2026NCT07552779Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 28, 2026NCT07552779Status: ACTIVE_NOT_RECRUITING → COMPLETED
MEDIUMJun 30, 2026NCT07552779Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 30, 2026NCT07552779Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 30, 2026NCT07552779Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about Ibuzatrelvir co-process API film coated

What is Ibuzatrelvir used for?

Ibuzatrelvir is an investigational small molecule being studied for the treatment of Coronavirus Disease 2019 (COVID-19). It is being developed by Pfizer, Inc. (PFE) and is currently in Phase 1 clinical development for this infectious disease indication.

Who makes Ibuzatrelvir?

Ibuzatrelvir is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for the treatment of COVID-19.

What phase is Ibuzatrelvir in?

Ibuzatrelvir is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of the drug has been completed, and it remains under investigation for the treatment of COVID-19.

What clinical trials is Ibuzatrelvir in?

Ibuzatrelvir has one completed Phase 1 clinical trial, registered as NCT07552779. This study, conducted in Belgium, evaluated how the drug is taken up into the blood of healthy adults after taking different tablet formulations. The trial enrolled 17 participants.

Is Ibuzatrelvir the same as Paxlovid?

No, Ibuzatrelvir is not the same as Paxlovid. Paxlovid is a combination of nirmatrelvir and ritonavir, while Ibuzatrelvir is a separate investigational compound. Ibuzatrelvir is being studied as a potential treatment for COVID-19, but it is a distinct drug candidate.