NCT05923411

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-07-11
• Primary completion: 2024-06-23
• Completion: 2024-07-19
• First posted: 2023-06-28
• Last updated: 2024-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study