Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07321332/RITONAVIR ORAL POWDER IN 3 DIFFERENT DELIVERY VEHICLES RELATIVE TO THE COMMERCIAL PF-07321332/RITONAVIR TABLETS IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS

Conditions
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Bioavailability

Intervention / Treatment
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* Drug: PF-07321332/ritonavir
* Drug: PF-07321332/ritonavir
* Drug: PF-07321332/ritonavir
* Drug: PF-07321332/ritonavir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A: PF-07321332/ritonavir<br>PF-07321332 ritonavir | Drug: PF-07321332/ritonavir<br>* Single oral dose of PF-07321332/ritonavir under fasted conditions<br>|
| Experimental: Treatment B: PF-07321332/ritonavir<br>PF-07321332/ritonavir mixed with water | Drug: PF-07321332/ritonavir<br>* Single oral dose of PF-07321332/ritonavir mixed with water under fasted conditions<br>|
| Experimental: Treatment C: PF-07321332/ritonavir<br>PF-07321332/ritonavir mixed with applesauce | Drug: PF-07321332/ritonavir<br>* Single oral dose of PF-07321332/ritonavir mixed with applesauce under fasted conditions<br>|
| Experimental: Treatment D: PF-07321332/ritonavir<br>PF-07321332/ritonavir mixed with vanilla pudding | Drug: PF-07321332/ritonavir<br>* Single oral dose of PF-07321332/ritonavir mixed with vanilla pudding under fasted conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve from time zero to 72 hours post dose |  | 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours | 
| Peak plasma concentration (Cmax) |  | 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) |  | Baseline (Day 0) up to 28 days after last dose of study medication | 
| Number of Participants With Notable Electrocardiogram (ECG) Values |  | Baseline (Day 0) up to day 4 of treatment period 4 | 
| Number of Participants With Clinically Notable Vital Signs |  | Baseline (Day 0) up to day 4 of treatment period 4 | 
| Number of Participants With Clinically Notable Changes in Clinical laboratory |  | Baseline (Day 0) up to day 4 of treatment period 4 | 
| Number of Participants With Clinically Notable Abnormality in physical examination |  | Baseline (Day 0) up to day 4 of treatment period 4 | 
| Palatability assessment of PF-07321332/ritonavir oral powder mixed with water/applesauce/vanilla pudding |  | 1, 5, 10 and 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronavirus disease 2019 (COVID-19), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Nirmatrelvir