A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People

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

94 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 medicine called PF-07817883 in healthy people. It aims to see if the medicine is safe and how it moves through the body. The study also looks at how food and other drugs might affect the medicine.

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.

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