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A Study for Multiple Tablet Forms of The Study Medicine (PF-07220060) in Healthy Adults
Sponsor: Pfizer
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.
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
113
Start Date
2023-07-11
Completion Date
2024-07-19
Last Updated
2026-06-04
Healthy Volunteers
Yes
Conditions
Interventions
Single dose of PF-07220060 as first Tablet Formulation
A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions.
Single dose of PF-07220060 as second Tablet Formulation
A single dose of PF-0720060 as the second Tablet Formulation administered under fasting conditions
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
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
Single dose of PF-07220060 as a Tablet Formulation
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 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).
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)
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
Locations (1)
New Haven Clinical Research Unit
New Haven, Connecticut, United States