Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants
Condition: Healthy Participants
Intervention: PF-07321332/ritonavir; Ritonavir
Intervention description: Single oral dose of PF-07321332 300 mg (2 × 150 mg tablets)/ritonavir 100 mg under fed or fasted conditions at 0 hour on Day 1; Single oral dose of ritonavir 100 mg at -12 hours prior to PF-07321332/ritonavir dosing, and ritonavir 100 mg will be dosed at 12 hours after PF-07321332/ritonavir dosing.
Intervention MeSH terms: Ritonavir; Nirmatrelvir
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: food effect; COVID-19 (Coronavirus disease 2019); SARS-CoV (severe acute respiratory syndrome coronavirus)

Summary:

      This is a Phase 1, open label, single dose, randomized, 2-treatment, 2-sequence, 2-period
      crossover study to evaluate the effect of high-fat meal on the relative bioavailability of
      PF-07321332 boosted with ritonavir following single dose oral administration of PF-07321332
      in combination with ritonavir using 150 mg tablet formulation of PF-07321332 in healthy adult
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants who are healthy as determined by medical evaluation
             including medical history, physical examination, laboratory tests, vital signs and
             12-lead ECGs. Female participants of childbearing potential must have a negative
             pregnancy test.

          -  Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

        Exclusion Criteria:

          -  Positive test result (RT-PCR) 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 brady-arrhythmias) or indicating serious underlying heart disease (eg,
             prolonged PR interval, cardiomyopathy, heart failure, 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 C antibody
             (HCVAb). Hepatitis B vaccination is allowed.

          -  Other medical or psychiatric condition including recent (within the past year) or
             active suicidal ideation/behavior or laboratory abnormality or other conditions or
             situations related to COVID-19 pandemic (eg,. contact with positive case, residence,
             or travel to an area with high incidence) that may increase the risk of study
             participation or, in the investigator's judgment, make the participant inappropriate
             for the study.