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

Bioavailability Clinical Trial

Official title:

A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07321332 FOLLOWING ORAL ADMINISTRATION OF 4 DIFFERENT FORMULATIONS RELATIVE TO THE COMMERCIAL TABLET FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05263895
• Other study ID #: C4671008
• Status: Completed
• Phase: Phase 1
• Start date: March 3, 2022
• Est. completion date: May 16, 2022

Study information

• Verified date: June 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• PF-07321332/ritonavir
PF-07321332 ritonavir will be administered as single dose orally
• PF-07321332/ritonavir
PF-07321332 ritonavir will be administered as single oral dose orally.
• PF-07321332/ritonavir
PF-07321332 ritonavir will be administered as single oral dose orally.
• PF-07321332/ritonavir
PF-07321332 ritonavir will be administered as single oral dose orally.
• PF-07321332
PF-07321332 will be administered as single oral dose orally.

Locations

Country	Name	City	State
United States	New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)		Baseline (Day 0) up to 28 days after last dose of study medication
Secondary	Number of Participants With Notable Electrocardiogram (ECG) Values		Baseline (Day 0) up to day 4 of treatment period 5
Secondary	Number of Participants With Clinically Notable Vital Signs		Baseline (Day 0) up to day 4 of treatment period 5
Secondary	Number of Participants With Clinically Notable Changes in Clinical laboratory		Baseline (Day 0) up to day 4 of treatment period 5
Secondary	Number of Participants With Clinically Notable Abnormality in physical examination		Baseline (Day 0) up to day 4 of treatment period 5

External Links

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