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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Single dose of PF-07220060 as third tablet formulation; Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration; Drug: Single dose of PF-07220060 as second Tablet Formulation; Drug: Single dose of PF-07220060 as first Tablet Formulation; Drug: Single dose of PF-07220060 as a Tablet Formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05923411

C4391007

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 8 patient groups

Cohort 1

Experimental group

Description:

Participants will receive PF-07220060 tablet by mouth

Treatment:

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

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

Cohort 2

Experimental group

Description:

Participants will receive PF-07220060 tablet by mouth

Treatment:

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

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

Cohort 3

Experimental group

Description:

Participants will receive PF-07220060 tablet by mouth

Treatment:

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

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

Cohort 4

Experimental group

Description:

Participants will receive PF-07220060 tablet by mouth

Treatment:

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

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

Cohort 5

Experimental group

Description:

Participants will receive PF-07220060 tablet by mouth

Treatment:

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

Cohort 6

Experimental group

Description:

Participants will receive PF-07220060 and Rabeprazole tablets by mouth

Treatment:

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

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

Cohort 7

Experimental group

Description:

Participants will receive PF-07220060 and Rabeprazole tablet by mouth

Treatment:

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

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

Cohort 8

Experimental group

Description:

Participants will receive PF-07220060 tablet by mouth

Treatment:

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