A Study for Multiple Tablet Forms of The Study Medicine (PF-07220060) in Healthy Adults
NCT05923411 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113
Last updated 2024-07-26
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
Interventions
- 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.
- 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
- 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
- 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
- DRUG
-
Single dose of PF-07220060 as a Tablet Formulation
A single dose of PF-07220060 as a tablet formulation administered under fed conditions
- 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).
- 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)
- 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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-11
- Primary Completion
- 2024-06-23
- Completion
- 2024-07-19
- FDA Drug
- Yes
Countries
- United States
Study Locations
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