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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PF-07817883; Drug: Midazolam; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05580003

C5091001

2022-002871-12 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Combined 6-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3: Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5: Drug-drug interaction with midazolam Part-6: Supratherapeutic exposure Part-1,2 and 6 are double blind, sponsor open and Part-3,4 and 5 are open label study.

Enrollment: 94 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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94 participants in 25 patient groups, including a placebo group

PF-07817883 Dose 1 in PART-1

Experimental group

Treatment:

Drug: PF-07817883

PF-07817883 Dose 2 in PART-1

Experimental group

Treatment:

Drug: PF-07817883

PF-07817883 Dose 3 in PART-1

Experimental group

Treatment:

Drug: PF-07817883

PF-07817883 Dose 4 in PART-1

Experimental group

Treatment:

Drug: PF-07817883

PF-07817883 Dose 5 in PART-1

Experimental group

Description:

Optional dose levels

Treatment:

Drug: PF-07817883

PF-07817883 Dose 6 in PART-1

Experimental group

Description:

Optional dose levels

Treatment:

Drug: PF-07817883

Placebo in PART-1

Placebo Comparator group

Description:

A single dose of placebo

Treatment:

Drug: Placebo

PF-07817883 DR1 in PART-2

Experimental group

Description:

DR=Dosing regimen; twice a day

Treatment:

Drug: PF-07817883

PF-07817883 DR2 in PART-2

Experimental group

Treatment:

Drug: PF-07817883

PF-07817883 DR3 in PART-2

Experimental group

Description:

Optional dosing regimen

Treatment:

Drug: PF-07817883

PF-07817883 DR4 in PART-2

Experimental group

Description:

Optional dosing regimen

Treatment:

Drug: PF-07817883

PF-07817883 in Japanese in PART-2

Experimental group

Description:

Optional dosing regimen to be studied in Japanese population

Treatment:

Drug: PF-07817883

PF-07817883 in Chinese in PART-2

Experimental group

Description:

Optional dosing regimen to be studied in Chinese population

Treatment:

Drug: PF-07817883

Placebo in PART-2

Placebo Comparator group

Treatment:

Drug: Placebo

PF-07817883 Suspension Fasted in PART-3

Experimental group

Description:

PART-3 is optional

Treatment:

Drug: PF-07817883

PF-07817883 FORM-1 Fasted in PART-3

Experimental group

Description:

First solid oral formulation (FORM1)

Treatment:

Drug: PF-07817883

PF-07817883 FORM-2 Fasted in PART-3

Experimental group

Description:

Second solid oral formulations (FORM-2) is optional

Treatment:

Drug: PF-07817883

PF-07817883 FORM-1 Fed in PART-3

Experimental group

Treatment:

Drug: PF-07817883

PF-07817883 FORM-2 Fed in PART-3

Experimental group

Treatment:

Drug: PF-07817883

PF-07817883 in PART-4

Experimental group

Description:

PART-4 is optional

Treatment:

Drug: PF-07817883

Midazolam 5 mg in PART-5

Experimental group

Description:

Single dose of 5 mg alone

Treatment:

Drug: Midazolam

Midazolam 5 mg with PF-07817883 in PART-5

Experimental group

Description:

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

Treatment:

Drug: Midazolam

Drug: PF-07817883

PF-07817883 in PART-6

Experimental group

Description:

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

Treatment:

Drug: PF-07817883

Placebo in PART-6

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Moxifloxacin 400 mg in PART-6 (open label)

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin

Drug: Placebo