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Healthy ParticipantsPhase 1NCT05923411

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

A Phase 1 study testing Single dose of PF-07220060 as first Tablet Formulation, Single dose of PF-07220060 as second Tablet Formulation and Single dose of PF-07220060 as a Tablet Formulation in people with Healthy Participants, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Single dose of PF-07220060 as first Tablet Formulation, Single dose of PF-07220060 as second Tablet Formulation and Single dose of PF-07220060 as a Tablet Formulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
1 siteUnited States
Study dates
11 Jul 2023to 19 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: 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:

Read more
  • 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.

Being tested
Single dose of PF-07220060 as first Tablet Formulation, Single dose of PF-07220060 as second Tablet Formulation, Single dose of PF-07220060 as a Tablet Formulation, Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration, Single dose of PF-07220060 as third tablet formulation
Keywords
Food-effect, Relative Bioavailability, Pharmacokinetics, Proton Pump Inhibitor (PPI), Cyclin-Dependent Kinase 4 (CDK4) inhibitor, Rabeprazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single dose of PF-07220060 as first Tablet FormulationDrug

    Also called Cohort 1, first Tablet Formulation, Fasted

    A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions.

  • Single dose of PF-07220060 as second Tablet FormulationDrug

    Also called Cohort 2, second Tablet Formulation, Fasted

    A single dose of PF-0720060 as the second Tablet Formulation administered under fasting conditions

  • Single dose of PF-07220060 as first Tablet FormulationDrug

    Also called Cohort 3, first Tablet Formulation, Second Dose Level, Fasted

    A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions at a second dose level

  • Single dose of PF-07220060 as second Tablet FormulationDrug

    Also called Cohort 4, second Tablet Formulation, Second Dose level, Fasted

    A single dose of PF-07220060 as the second Tablet Formulation administered under fasting conditions at a second dose level

  • Single dose of PF-07220060 as a Tablet FormulationDrug

    Also called Cohort 5, Fed

    A single dose of PF-07220060 as a tablet formulation administered under fed conditions

  • Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administrationDrug

    Also called Cohort 6, Fasted PPI

    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).

  • Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administrationDrug

    Also called Cohort 7, Fed PPI

    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)

  • Single dose of PF-07220060 as third tablet formulationDrug

    Also called Cohort 8, 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

Study groups in NCT05923411
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants will receive PF-07220060 tablet by mouth
Receives: Drug: Single dose of PF-07220060 as first Tablet Formulation
Cohort 2ExperimentalParticipants will receive PF-07220060 tablet by mouth
Receives: Drug: Single dose of PF-07220060 as second Tablet Formulation
Cohort 3ExperimentalParticipants will receive PF-07220060 tablet by mouth
Receives: Drug: Single dose of PF-07220060 as first Tablet Formulation
Cohort 4ExperimentalParticipants will receive PF-07220060 tablet by mouth
Receives: Drug: Single dose of PF-07220060 as second Tablet Formulation
Cohort 5ExperimentalParticipants will receive PF-07220060 tablet by mouth
Receives: Drug: Single dose of PF-07220060 as a Tablet Formulation
Cohort 6ExperimentalParticipants will receive PF-07220060 and Rabeprazole tablets by mouth
Receives: Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration
Cohort 7ExperimentalParticipants will receive PF-07220060 and Rabeprazole tablet by mouth
Receives: Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration
Cohort 8ExperimentalParticipants will receive PF-07220060 tablet by mouth
Receives: Drug: Single dose of PF-07220060 as third tablet formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. Maximum Observed Plasma Concentration (Cmax) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations

    Measured: 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 outcomes (14)
  1. AUCinf of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level

    Measured: 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

  2. Cmax of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level

    Measured: 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

  3. 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)

    Measured: 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

  4. Maximum Observed Plasma Concentration (Cmax) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations (third formulation)

    Measured: 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

  5. AUCinf of PF-07220060 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a PF-07220060 tablet formulation

    Measured: 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

  6. Cmax of PF-07220060 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a PF-07220060 tablet formulation

    Measured: 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

  7. AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition

    Measured: 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

  8. Cmax of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition

    Measured: 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

  9. AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition

    Measured: 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

  10. Cmax of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition

    Measured: 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

  11. Number of Participants With Laboratory Abnormalities

    Measured: From baseline up to 28 days after PF-07220060 dose

  12. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings

    Measured: From baseline up to 28 days after PF-07220060

  13. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Measured: From baseline up to 28 days after PF-07220060

  14. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Measured: From baseline up to 28 days after PF-07220060 dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start11 Jul 2023
  3. Primary completion23 Jun 2024
  4. Study completion19 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923411
Sponsor's protocol ID
C4391007
Other IDs
NCT05923411
Status last verified
Jun 2025
First submitted
20 Jun 2023
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Single dose of PF-07220060 as first Tablet Formulation, Single dose of PF-07220060 as second Tablet Formulation and Single dose of PF-07220060 as a Tablet Formulation in people with Healthy Participants, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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Clinical Trial NCT05923411 | AzTrials