Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation

Phase 1

Completed

• Conditions: Bioavailability
• Interventions: Drug: PF-07321332/ritonavir; Drug: PF-07321332

• Registration Number: NCT05263895
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to estimate the relative bioavailability of PF-07321332 in different formulations in healthy adult participants.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-02-25
• Study Start: 2022-03-03
• Study First Posted: 2022-03-03
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-16
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A: PF-0732133/ritonavir	PF-07321332/ritonavir	PF-07321332 ritonavir
Treatment B: PF-07321332/ritonavir	PF-07321332/ritonavir	PF-07321332 ritonavir
Treatment C: PF-07321332/ritonavir	PF-07321332/ritonavir	PF-07321332 ritonavir
Treatment D: PF-07321332/ritonavir	PF-07321332/ritonavir	PF-07321332 ritonavir
Treatment E: PF-07321332	PF-07321332	PF-07321332

Primary Outcome Measures

Name	Time	Method
Area under the Concentration-Time Curve (AUC)	0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours
Maximum Observed 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

Name	Time	Method
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 5
Number of Participants With Clinically Notable Vital Signs	Baseline (Day 0) up to day 4 of treatment period 5
Number of Participants With Clinically Notable Changes in Clinical laboratory	Baseline (Day 0) up to day 4 of treatment period 5
Number of Participants With Clinically Notable Abnormality in physical examination	Baseline (Day 0) up to day 4 of treatment period 5

Trial Locations

Locations (1)

New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States