PF-07817883 for COVID-19

No longer recruiting at 2 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Prescription drugs, Herbal supplements

Disqualifiers: COVID-19 vaccine, Tobacco, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if PF-07817883 (Ibuzatrelvir) is safe and how it moves through the body. Researchers are studying PF-07817883 as a potential treatment for COVID-19. Participants will take the drug orally, possibly up to twice a day. The trial will also examine how diet might affect the drug and whether it interacts with midazolam. The study seeks healthy individuals without major health issues who identify as Japanese or Chinese based on their family's background. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or nonprescription drugs, as well as dietary and herbal supplements, at least 28 days before the first dose of the study medicine.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Ibuzatrelvir (PF-07817883) is generally safe for people. Studies have found it causes no more side effects than a sugar pill. Early results suggest few safety concerns, reassuring those considering joining a trial. Notably, this treatment has been tested on healthy individuals, and no major safety issues have been reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07817883 because it appears to have a unique mechanism of action distinct from standard treatments. While most current options might target specific symptoms or pathways, PF-07817883 is being studied for its safety and how it behaves in the body in different dosing regimens, including various formulations and intake conditions (fed versus fasted). This versatility in administration could lead to more tailored treatment plans for different populations, like Japanese and Chinese individuals, potentially improving effectiveness and reducing side effects. Additionally, the trial includes comparisons with known medications like midazolam and moxifloxacin, highlighting its potential to be integrated into existing therapeutic frameworks. Researchers hope these features will make PF-07817883 a promising new option for addressing unmet needs in treatment.

What evidence suggests that PF-07817883 might be an effective treatment for COVID-19?

Research has shown that PF-07817883, also known as ibuzatrelvir, is a pill developed to treat COVID-19. It blocks a specific enzyme the virus needs to multiply. Lab tests have demonstrated that ibuzatrelvir is very effective against the virus and poses a low risk of safety concerns. In studies with high-risk patients who were not hospitalized, it helped prevent severe cases of COVID-19. These results suggest that PF-07817883 could be a promising treatment for people with COVID-19. Participants in this trial will receive different dosing regimens of PF-07817883 to evaluate its effectiveness and safety. ^{3 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Inclusion Criteria

Japanese subjects who have four Japanese biologic grandparents born in Japan

Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs). A body weight of >45 kg may be considered in selected cases.

Chinese participants who were born in mainland China and both parents are of the Chinese descent.

Exclusion Criteria

Have received COVID-19 vaccine within 7 days before screening or have received only one of the 2 required doses of COVID-19 vaccine

Positive test result for SARS-CoV-2 infection at the time of screening or Day-1.

Use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose

Participants receive single ascending doses of PF-07817883 to evaluate safety and pharmacokinetics

Up to 48 days

Multiple Ascending Dose

Participants receive multiple ascending doses of PF-07817883 to evaluate safety and pharmacokinetics

Up to 55 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07817883

How Is the Trial Designed?

Group I: PF-07817883 in PART-6 Experimental Treatment 1 Intervention

A single dose at supratherapeutic exposure administered as divided doses (1h apart)

Group II: PF-07817883 in PART-4 Experimental Treatment 1 Intervention

PART-4 is optional

Group III: PF-07817883 in Japanese in PART-2 Experimental Treatment 1 Intervention

Optional dosing regimen to be studied in Japanese population

Group IV: PF-07817883 in Chinese in PART-2 Experimental Treatment 1 Intervention

Optional dosing regimen to be studied in Chinese population

Group V: PF-07817883 Suspension Fasted in PART-3 Experimental Treatment 1 Intervention

PART-3 is optional

Group VI: PF-07817883 FORM-2 Fed in PART-3 Experimental Treatment 1 Intervention

Group VII: PF-07817883 FORM-2 Fasted in PART-3 Experimental Treatment 1 Intervention

Second solid oral formulations (FORM-2) is optional

Group VIII: PF-07817883 FORM-1 Fed in PART-3 Experimental Treatment 1 Intervention

Group IX: PF-07817883 FORM-1 Fasted in PART-3 Experimental Treatment 1 Intervention

First solid oral formulation (FORM1)

Group X: PF-07817883 Dose 6 in PART-1 Experimental Treatment 1 Intervention

Optional dose levels

Group XI: PF-07817883 Dose 5 in PART-1 Experimental Treatment 1 Intervention

Optional dose levels

Group XII: PF-07817883 Dose 4 in PART-1 Experimental Treatment 1 Intervention

Group XIII: PF-07817883 Dose 3 in PART-1 Experimental Treatment 1 Intervention

Group XIV: PF-07817883 Dose 2 in PART-1 Experimental Treatment 1 Intervention

Group XV: PF-07817883 Dose 1 in PART-1 Experimental Treatment 1 Intervention

Group XVI: PF-07817883 DR4 in PART-2 Experimental Treatment 1 Intervention

Optional dosing regimen

Group XVII: PF-07817883 DR3 in PART-2 Experimental Treatment 1 Intervention

Optional dosing regimen

Group XVIII: PF-07817883 DR2 in PART-2 Experimental Treatment 1 Intervention

Group XIX: PF-07817883 DR1 in PART-2 Experimental Treatment 1 Intervention

DR=Dosing regimen; twice a day

Group XX: Midazolam 5 mg with PF-07817883 in PART-5 Experimental Treatment 2 Interventions

Single dose of 5 mg on Day 10 with multiple doses (twice a day) of PF-07817883

Group XXI: Midazolam 5 mg in PART-5 Experimental Treatment 1 Intervention

Single dose of 5 mg alone

Group XXII: Moxifloxacin 400 mg in PART-6 (open label) Active Control 2 Interventions

Moxifloxacin 400 mg at 0h followed by placebo at 1h

Group XXIII: Placebo in PART-2 Placebo Group 1 Intervention

Group XXIV: Placebo in PART-6 Placebo Group 1 Intervention

A single dose of placebo administered as divided doses (1h apart)

Group XXV: Placebo in PART-1 Placebo Group 1 Intervention

A single dose of placebo

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.

pfizer.com

pfizer.com/sites/default/files/plsr-studies/C5091013%20Plain%20Language%20Study%20Results%20Summary%20%28PLSRS%29%20Phase%201%20PK%20Primary%20Endpoint.pdf

Clinical Study Results

The main aim of this study was to find out how much of ibuzatrelvir enters the blood when healthy adult participants took ibuzatrelvir as ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05580003

A Study to Learn Safety and Blood Levels of PF-07817883 ...

The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people.

3.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/PFE-N/pressreleases/35744751/pfizers-phase-3-study-on-ibuzatrelvir-a-potential-game-changer-for-covid-19-treatment/

Pfizer's Phase 3 Study on Ibuzatrelvir: A Potential Game ...

' The study aims to evaluate the efficacy and safety of ibuzatrelvir in preventing severe COVID-19 in non-hospitalized patients at high risk of ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39486089/

Virologic Response and Safety of Ibuzatrelvir, A Novel ...

Ibuzatrelvir is an orally bioavailable SARS-CoV-2 Mpro inhibitor with demonstrated in vitro antiviral activity and low potential for safety concerns.

5.

trial.medpath.com

trial.medpath.com/drug/report/283c998491dced0e

ibuzatrelvir | Advanced Drug Monograph - MedPath

Ibuzatrelvir (PF-07817883): A Comprehensive Profile of a Second-Generation Oral Antiviral for the Treatment of COVID-19. Executive Summary.

6.

leap.epa.ie

leap.epa.ie/docs/be5d4bc1-e427-4fe4-86e2-66ab72a9e94d.pdf

SAFETY DATA SHEET

PF-07817883 MCC Co-Processed. Product Code(s). PF01337. Trade Name: Not applicable. Chemical Family: Not determined. 1.2. Relevant identified uses of the ...

7.

medchemexpress.com

medchemexpress.com/ibuzatrelvir.html?srsltid=AfmBOoqyOBdkwFdRjuvQzRN4vOmg-gmklTvl76mi3XMjF93qiiBWVbcj

Ibuzatrelvir (PF-07817883) | Virul protease Inhibitor

Ibuzatrelvir is well tolerated with a safety profile similar to placebo and prevents viral infection and transmission. Ibuzatrelvir can be used to inhibit COVID ...

8.

academic.oup.com

academic.oup.com/cid/article/80/3/673/7863440

Virologic Response and Safety of Ibuzatrelvir, A Novel SARS ...

Ibuzatrelvir is an orally bioavailable SARS-CoV-2 M pro inhibitor with demonstrated in vitro antiviral activity and low potential for safety concerns.

9.

file.medchemexpress.com

file.medchemexpress.com/batch_PDF/HY-156654/Ibuzatrelvir-SDS-MedChemExpress.pdf

Safety Data Sheet

None. 3. COMPOSITION/INFORMATION ON INGREDIENTS. 3.1 Substances. Synonyms: PF-07817883. Formula: C21H30F3N5O5. Molecular Weight: 489.49. CAS No ...