94 Participants Needed

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

Recruiting at 2 trial locations
PC
Overseen ByPfizer CT.gov Call Center

Trial Summary

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.

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.

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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.
See 3 more

Timeline

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

Treatment Details

Interventions

  • PF-07817883
Participant Groups
25Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PF-07817883 in PART-6Experimental Treatment1 Intervention
A single dose at supratherapeutic exposure administered as divided doses (1h apart)
Group II: PF-07817883 in PART-4Experimental Treatment1 Intervention
PART-4 is optional
Group III: PF-07817883 in Japanese in PART-2Experimental Treatment1 Intervention
Optional dosing regimen to be studied in Japanese population
Group IV: PF-07817883 in Chinese in PART-2Experimental Treatment1 Intervention
Optional dosing regimen to be studied in Chinese population
Group V: PF-07817883 Suspension Fasted in PART-3Experimental Treatment1 Intervention
PART-3 is optional
Group VI: PF-07817883 FORM-2 Fed in PART-3Experimental Treatment1 Intervention
Group VII: PF-07817883 FORM-2 Fasted in PART-3Experimental Treatment1 Intervention
Second solid oral formulations (FORM-2) is optional
Group VIII: PF-07817883 FORM-1 Fed in PART-3Experimental Treatment1 Intervention
Group IX: PF-07817883 FORM-1 Fasted in PART-3Experimental Treatment1 Intervention
First solid oral formulation (FORM1)
Group X: PF-07817883 Dose 6 in PART-1Experimental Treatment1 Intervention
Optional dose levels
Group XI: PF-07817883 Dose 5 in PART-1Experimental Treatment1 Intervention
Optional dose levels
Group XII: PF-07817883 Dose 4 in PART-1Experimental Treatment1 Intervention
Group XIII: PF-07817883 Dose 3 in PART-1Experimental Treatment1 Intervention
Group XIV: PF-07817883 Dose 2 in PART-1Experimental Treatment1 Intervention
Group XV: PF-07817883 Dose 1 in PART-1Experimental Treatment1 Intervention
Group XVI: PF-07817883 DR4 in PART-2Experimental Treatment1 Intervention
Optional dosing regimen
Group XVII: PF-07817883 DR3 in PART-2Experimental Treatment1 Intervention
Optional dosing regimen
Group XVIII: PF-07817883 DR2 in PART-2Experimental Treatment1 Intervention
Group XIX: PF-07817883 DR1 in PART-2Experimental Treatment1 Intervention
DR=Dosing regimen; twice a day
Group XX: Midazolam 5 mg with PF-07817883 in PART-5Experimental Treatment2 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-5Experimental Treatment1 Intervention
Single dose of 5 mg alone
Group XXII: Moxifloxacin 400 mg in PART-6 (open label)Active Control2 Interventions
Moxifloxacin 400 mg at 0h followed by placebo at 1h
Group XXIII: Placebo in PART-2Placebo Group1 Intervention
Group XXIV: Placebo in PART-6Placebo Group1 Intervention
A single dose of placebo administered as divided doses (1h apart)
Group XXV: Placebo in PART-1Placebo Group1 Intervention
A single dose of placebo

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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