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

NCT05923411 | Completed Phase 1 FDA Drug

• 1 other identifier: C4391007
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Participants

Keywords

Food-effect; Relative Bioavailability; Pharmacokinetics; Proton Pump Inhibitor (PPI); Cyclin-Dependent Kinase 4 (CDK4) inhibitor; Rabeprazole

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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

• 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

• 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

Study Arms (8)

Cohort 1

EXPERIMENTAL

Participants will receive PF-07220060 tablet by mouth

Drug: Single dose of PF-07220060 as first Tablet Formulation

Cohort 2

EXPERIMENTAL

Participants will receive PF-07220060 tablet by mouth

Drug: Single dose of PF-07220060 as second Tablet Formulation

Cohort 3

EXPERIMENTAL

Participants will receive PF-07220060 tablet by mouth

Drug: Single dose of PF-07220060 as first Tablet Formulation

Cohort 4

EXPERIMENTAL

Participants will receive PF-07220060 tablet by mouth

Drug: Single dose of PF-07220060 as second Tablet Formulation

Cohort 5

EXPERIMENTAL

Participants will receive PF-07220060 tablet by mouth

Drug: Single dose of PF-07220060 as a Tablet Formulation

Cohort 6

EXPERIMENTAL

Participants will receive PF-07220060 and Rabeprazole tablets by mouth

Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration

Cohort 7

EXPERIMENTAL

Participants will receive PF-07220060 and Rabeprazole tablet by mouth

Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration

Cohort 8

EXPERIMENTAL

Participants will receive PF-07220060 tablet by mouth

Drug: Single dose of PF-07220060 as third tablet formulation

Interventions

Single dose of PF-07220060 as first Tablet Formulation DRUG

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

Also known as: Cohort 1, first Tablet Formulation, Fasted

Cohort 1

Single dose of PF-07220060 as second Tablet Formulation DRUG

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

Also known as: Cohort 2, second Tablet Formulation, Fasted

Cohort 2

Single dose of PF-07220060 as a Tablet Formulation DRUG

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

Also known as: Cohort 5, Fed

Cohort 5

Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration DRUG

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).

Also known as: Cohort 6, Fasted PPI

Cohort 6

Single dose of PF-07220060 as third tablet formulation DRUG

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

Also known as: Cohort 8, third tablet formulation

Cohort 8

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 28, 2023
• Study Start: July 11, 2023
• Primary Completion: June 23, 2024
• Study Completion: July 19, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)