A Study for Multiple Tablet Forms of The Study Medicine (PF-07220060) in Healthy Adults

A PHASE 1, RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF TWO TABLET FORMULATIONS OF PF-07220060, AND TO INVESTIGATE THE EFFECT OF FOOD AND A PROTON PUMP INHIBITOR ON THE RELATIVE BIOAVAILABILITY OF PF-07220060

The purpose of this study is to compare multiple formulations of PF-07220060 in terms of their uptake into the blood stream. The study will assess the effects of food and Rabeprazole on the uptake of PF-07220060. Rabeprazole belongs to a type of medications called proton pump inhibitors. In reality, some patients may take both PF-07220060 and rabeprazole together.

This study is seeking participants that are:

- Healthy male or female aged 18 to 65 years

Participants in this study will receive PF-07220060 once or twice by mouth. The participants may receive different tablets for PF-07220060. Some participants will take a meal before receiving PF-07220060. In addition, some participants will take rabeprazole by mouth for 7 days before taking PF-07220060.

The study will compare experiences of people receiving different formulations of PF-07220060. Experiences of people taking food and rabeprazole with PF-07220060 will be compared to those on PF-07220060 alone. This will help understand how much PF-07220060 is taken up into the blood. It will also help understand how meal and Rabeprazole medicine changes the uptake of PF-07220060 into the blood.

Participants will take part in the study for a maximum of 74 days. During this time, they will have to stay onsite for 5 to 13 days. There will be up to 2 onsite study visits.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Single dose of PF-07220060 as first Tablet Formulation; Drug: Single dose of PF-07220060 as first Tablet Formulation; Drug: Single dose of PF-07220060 as second Tablet Formulation; Drug: Single dose of PF-07220060 as second Tablet Formulation; Drug: Single dose of PF-07220060 as a Tablet Formulation; Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration; Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration; Drug: Single dose of PF-07220060 as third tablet formulation

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
• BMI of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
• Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.

Exclusion Criteria:

• 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).
• 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 antigen (HCVAb). Hepatitis B vaccination is allowed.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Prior/Concomitant Therapy:

• 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.
• Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
• A positive urine drug test/urine cotinine test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants will receive PF-07220060 tablet by mouth	Drug: Single dose of PF-07220060 as first Tablet Formulation; A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions.; Other Names: Cohort 1, first Tablet Formulation, Fasted; Drug: Single dose of PF-07220060 as first Tablet Formulation; A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions at a second dose level; Other Names: Cohort 3, first Tablet Formulation, Second Dose Level, Fasted
Experimental: Cohort 2; Participants will receive PF-07220060 tablet by mouth	Drug: Single dose of PF-07220060 as second Tablet Formulation; A single dose of PF-0720060 as the second Tablet Formulation administered under fasting conditions; Other Names: Cohort 2, second Tablet Formulation, Fasted; Drug: Single dose of PF-07220060 as second Tablet Formulation; A single dose of PF-07220060 as the second Tablet Formulation administered under fasting conditions at a second dose level; Other Names: Cohort 4, second Tablet Formulation, Second Dose level, Fasted
Experimental: Cohort 3; Participants will receive PF-07220060 tablet by mouth	Drug: Single dose of PF-07220060 as first Tablet Formulation; A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions.; Other Names: Cohort 1, first Tablet Formulation, Fasted; Drug: Single dose of PF-07220060 as first Tablet Formulation; A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions at a second dose level; Other Names: Cohort 3, first Tablet Formulation, Second Dose Level, Fasted
Experimental: Cohort 4; Participants will receive PF-07220060 tablet by mouth	Drug: Single dose of PF-07220060 as second Tablet Formulation; A single dose of PF-0720060 as the second Tablet Formulation administered under fasting conditions; Other Names: Cohort 2, second Tablet Formulation, Fasted; Drug: Single dose of PF-07220060 as second Tablet Formulation; A single dose of PF-07220060 as the second Tablet Formulation administered under fasting conditions at a second dose level; Other Names: Cohort 4, second Tablet Formulation, Second Dose level, Fasted
Experimental: Cohort 5; Participants will receive PF-07220060 tablet by mouth	Drug: Single dose of PF-07220060 as a Tablet Formulation; A single dose of PF-07220060 as a tablet formulation administered under fed conditions; Other Names: Cohort 5, Fed
Experimental: Cohort 6; Participants will receive PF-07220060 and Rabeprazole tablets by mouth	Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration; A 2-treatment fixed sequence of single dose of PF-07220060 tablets under fasting conditions followed by a single dose of PF-07220060 tablets under Proton Pump Inhibitor (PPI) administration under fasting condition (following a 7 day oral rabeprazole tablets daily administration).; Other Names: Cohort 6, Fasted PPI; Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration; A 2-treatment fixed sequence of a single dose of PF-07220060 tablet given with moderate-fat, standard-calorie meal followed by a single dose of PF-07220060 tablet given with moderate-fat, standard-calorie meal and under PPI administration (following a 7 day oral rabeprazole tablets daily administration); Other Names: Cohort 7, Fed PPI
Experimental: Cohort 7; Participants will receive PF-07220060 and Rabeprazole tablet by mouth	Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration; A 2-treatment fixed sequence of single dose of PF-07220060 tablets under fasting conditions followed by a single dose of PF-07220060 tablets under Proton Pump Inhibitor (PPI) administration under fasting condition (following a 7 day oral rabeprazole tablets daily administration).; Other Names: Cohort 6, Fasted PPI; Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration; A 2-treatment fixed sequence of a single dose of PF-07220060 tablet given with moderate-fat, standard-calorie meal followed by a single dose of PF-07220060 tablet given with moderate-fat, standard-calorie meal and under PPI administration (following a 7 day oral rabeprazole tablets daily administration); Other Names: Cohort 7, Fed PPI
Experimental: Cohort 8; Participants will receive PF-07220060 tablet by mouth	Drug: Single dose of PF-07220060 as third tablet formulation; A 2-period randomized 2-sequence cross over of a single dose of PF-07220060 as first and third tablet formulation under fasting conditions with a 6-day washout in between them; Other Names: Cohort 8, third tablet formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time(AUCinf) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
Maximum Observed Plasma Concentration (Cmax) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
AUCinf of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
Cmax of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
AUCinf of PF-07220060 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a PF-07220060 tablet formulation	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
Cmax of PF-07220060 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a PF-07220060 tablet formulation	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
Cmax of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
Cmax of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose
Number of Participants With Laboratory Abnormalities	From baseline up to 28 days after PF-07220060 dose
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings	From baseline up to 28 days after PF-07220060
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	From baseline up to 28 days after PF-07220060
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	From baseline up to 28 days after PF-07220060 dose
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time(AUCinf) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations (third formulation)	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours PF-07220060 post-dose
Maximum Observed Plasma Concentration (Cmax) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations (third formulation)	0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours PF-07220060 post-dose

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Actual): June 23, 2024
• Study Completion (Actual): July 19, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Rabeprazole; Relative Bioavailability; Proton Pump Inhibitor (PPI); Food-effect; Cyclin-Dependent Kinase 4 (CDK4) inhibitor
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: C4391007; NCT05923411 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No