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

• Status: Not yet recruiting
• Trial end date: 2023-03-16
• Target enrollment: 0
• Participant gender: All

Summary

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. PF-07817883 is for the potential treatment of COVID-19. Participants will take PF-07817883 by mouth up to 2 times a day. This study may also evaluate how much PF-07817883 gets into the body when taken as pill. We may study if people's diets can affect this study medicine. We may also examine how PF-07817883 is processed and removed by the human body. Finally, we may look into if PF-07817883 has potential to interact with midazolam.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• Healthy male or female subjects between ages of 18-60 years. Male only in part-4.

• 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.

• Japanese subjects who have four Japanese biologic grandparents born in Japan

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

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, intestinal resection).

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

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

• Use of tobacco or nicotine containing products in excess of the equivalents of 5 cigarettes per day or 2 chews of tobacco per day

• 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.