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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05263895
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 5
• Actual Duration (Months): 2.4
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bioavailability	Drug: PF-07321332/ritonavir; Drug: PF-07321332/ritonavir; Drug: PF-07321332/ritonavir; Drug: PF-07321332/ritonavir; Drug: PF-07321332	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Mar 3, 2022
• Actual Primary Completion Date: May 16, 2022
• Actual Study Completion Date: May 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment A: PF-0732133/ritonavir PF-07321332 ritonavir	Drug: PF-07321332/ritonavir; PF-07321332 ritonavir will be administered as single dose orally
Experimental: Treatment B: PF-07321332/ritonavir PF-07321332 ritonavir	Drug: PF-07321332/ritonavir; PF-07321332 ritonavir will be administered as single oral dose orally.
Experimental: Treatment C: PF-07321332/ritonavir PF-07321332 ritonavir	Drug: PF-07321332/ritonavir; PF-07321332 ritonavir will be administered as single oral dose orally.
Experimental: Treatment D: PF-07321332/ritonavir PF-07321332 ritonavir	Drug: PF-07321332/ritonavir; PF-07321332 ritonavir will be administered as single oral dose orally.
Experimental: Treatment E: PF-07321332 PF-07321332	Drug: PF-07321332; PF-07321332 will be administered as single oral dose orally.

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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

1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [Baseline (Day 0) up to 28 days after last dose of study medication]

2. Number of Participants With Notable Electrocardiogram (ECG) Values [Baseline (Day 0) up to day 4 of treatment period 5]

3. Number of Participants With Clinically Notable Vital Signs [Baseline (Day 0) up to day 4 of treatment period 5]

4. Number of Participants With Clinically Notable Changes in Clinical laboratory [Baseline (Day 0) up to day 4 of treatment period 5]

5. Number of Participants With Clinically Notable Abnormality in physical examination [Baseline (Day 0) up to day 4 of treatment period 5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Haven Clinical Research Unit	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05263895
• Other Study ID Numbers: C4671008
• First Posted: Mar 3, 2022
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: coronavirus disease 2019 (COVID-19); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
• Additional relevant MeSH terms: Ritonavir

Study Results

No Results Posted as of Jun 30, 2022