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

Pfizer113 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

113

Conditions

Healthy Participants

Interventions

Single dose of PF-07220060 as first Tablet FormulationDRUG

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

Single dose of PF-07220060 as second Tablet FormulationDRUG

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

Single dose of PF-07220060 as first Tablet FormulationDRUG

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

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

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

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

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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