CD2H COVID-19

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

Purpose

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.

Condition

Healthy

Eligibility

Eligible Ages: Between 18 Years and 60 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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.

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: PART-1 and -2 are a randomized, double-blind, sponsor-open, placebo-controlled trial to evaluate safety, tolerability and PK of single and multiple escalating oral doses of PF 07817883 in healthy adult participants, respectively. PART-1 is crossover while PART-2 is parallel cohort study design. PART-2 of the study may also evaluate the safety, tolerability and PK in Japanese and Chinese participants. PART-3 is a randomized, open-label, cross-over, study to evaluate relative bioavailability and food effect of up to 2 new PF 07817883 oral formulations. PART-4 is an open label, non-randomized, single period cohort to evaluate the metabolism and excretion of PF 07817883. PART-5 is an open-label, randomized, cross-over cohort to evaluate the effect of steady state PF-07817883 on PK of midazolam in healthy participants. PART-6 is a sponsor-open, randomized, 3-treatment, 3-period, cross over study to evaluate safety, tolerability, and PK of PF 07817883 at supratherapeutic exposure.
Primary Purpose: Other
Masking: Double (Participant, Investigator)
Masking Description: PART-1, 2 and 6 are double-blind, sponsor-open while PART-3, 4 and 5 are open label

Arm Groups

Arm	Description	Assigned Intervention
Experimental PF-07817883 Dose 1 in PART-1		Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 Dose 2 in PART-1		Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 Dose 3 in PART-1		Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 Dose 4 in PART-1		Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 Dose 5 in PART-1	Optional dose levels	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 Dose 6 in PART-1	Optional dose levels	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Placebo Comparator Placebo in PART-1	A single dose of placebo	Drug: Placebo Placebo suspension
Experimental PF-07817883 DR1 in PART-2	DR=Dosing regimen; twice a day	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 DR2 in PART-2		Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 DR3 in PART-2	Optional dosing regimen	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 DR4 in PART-2	Optional dosing regimen	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 in Japanese in PART-2	Optional dosing regimen to be studied in Japanese population	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 in Chinese in PART-2	Optional dosing regimen to be studied in Chinese population	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Placebo Comparator Placebo in PART-2		Drug: Placebo Placebo suspension
Experimental PF-07817883 Suspension Fasted in PART-3	PART-3 is optional	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 FORM-1 Fasted in PART-3	First solid oral formulation (FORM1)	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 FORM-2 Fasted in PART-3	Second solid oral formulations (FORM-2) is optional	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 FORM-1 Fed in PART-3		Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 FORM-2 Fed in PART-3		Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental PF-07817883 in PART-4	PART-4 is optional	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Experimental Midazolam 5 mg in PART-5	Single dose of 5 mg alone	Drug: Midazolam midazolam oral solution
Experimental Midazolam 5 mg with PF-07817883 in PART-5	Single dose of 5 mg on Day 10 with multiple doses (twice a day) of PF-07817883	Drug: PF-07817883 Oral suspension or solid oral formulation(s) Drug: Midazolam midazolam oral solution
Experimental PF-07817883 in PART-6	A single dose at supratherapeutic exposure administered as divided doses (1h apart)	Drug: PF-07817883 Oral suspension or solid oral formulation(s)
Placebo Comparator Placebo in PART-6	A single dose of placebo administered as divided doses (1h apart)	Drug: Placebo Placebo suspension
Active Comparator Moxifloxacin 400 mg in PART-6 (open label)	Moxifloxacin 400 mg at 0h followed by placebo at 1h	Drug: Placebo Placebo suspension Drug: Moxifloxacin Moxifloxacin 400 mg tablet

Recruiting Locations

More Details

NCT ID: NCT05580003
Status: Completed
Sponsor: Pfizer

Detailed 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.