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Purpose

The purpose of this study is to estimate the relative bioavailability of PF-07321332/ritonavir oral powder relative to the commercial tablet formulation under fasted condition in healthy adult participants. The study will also assess the effect of 3 different food vehicles on the relative bioavailability of the PF-07321332/ritonavir oral powder formulation as well as the safety, tolerability, and palatability of PF-07321332/ritonavir oral powder in healthy adult participants.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs. - Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). - Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria

  • Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1. - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). - Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome). - Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). - History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antibody (HCVAb). Hepatitis B vaccination is allowed. - Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. - Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period. - A positive urine drug test.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Treatment A: PF-07321332/ritonavir 		PF-07321332 ritonavir
  • Drug: PF-07321332/ritonavir
    Single oral dose of PF-07321332/ritonavir under fasted conditions
Experimental
Treatment B: PF-07321332/ritonavir 		PF-07321332/ritonavir mixed with water
  • Drug: PF-07321332/ritonavir
    Single oral dose of PF-07321332/ritonavir mixed with water under fasted conditions
Experimental
Treatment C: PF-07321332/ritonavir 		PF-07321332/ritonavir mixed with applesauce
  • Drug: PF-07321332/ritonavir
    Single oral dose of PF-07321332/ritonavir mixed with applesauce under fasted conditions
Experimental
Treatment D: PF-07321332/ritonavir 		PF-07321332/ritonavir mixed with vanilla pudding
  • Drug: PF-07321332/ritonavir
    Single oral dose of PF-07321332/ritonavir mixed with vanilla pudding under fasted conditions

Recruiting Locations

More Details

NCT ID
NCT05263921
Status
Completed
Sponsor
Pfizer

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.