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

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05923411

Collaborator

(none)

Enrollment

Arms

7.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two 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

All participants in this study will receive PF-07220060 once 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 two 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 71 days. During this time, they will have to stay onsite for 5 to 11 days. There will be up to 2 onsite study visits.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: Single dose of PF-07220060 as first Tablet Formulation 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 second Tablet Formulation Drug: Single dose of PF-07220060 as a Tablet Formulation 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	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A PHASE 1, RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP, SINGLE-DOSESTUDY 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 INHIBITORON THE RELATIVE BIOAVAILABILITY OF PF-07220060

Anticipated Study Start Date :

Jul 11, 2023

Anticipated Primary Completion Date :

Mar 8, 2024

Anticipated Study Completion Date :

Mar 8, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A (Cohort 1) Participants will receive PF-07220060 tablet by mouth	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. Other Names: Cohort 1, first Tablet Formulation, Fasted
Experimental: Treatment B (Cohort 2) Participants will receive PF-07220060 tablet by mouth	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 Other Names: Cohort 2, second Tablet Formulation, Fasted
Experimental: Treatment C (Cohort 3) Participants will receive PF-07220060 tablet by mouth	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 Other Names: Cohort 3, first Tablet Formulation, Second Dose Level, Fasted
Experimental: Treatment D (Cohort 4) Participants will receive PF-07220060 tablet by mouth	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 Other Names: Cohort 4, second Tablet Formulation, Second Dose level, Fasted
Experimental: Treatment E (Cohort 5) Participants will receive PF-07220060 tablet by mouth	Drug: Single dose of PF-07220060 as a Tablet Formulation A single dose of PF-07220060 as a tablet formulation administered under fed conditions Other Names: Cohort 5, Fed
Experimental: Treatment F (Cohort 6) Participants will receive PF-07220060 and Rabeprazole tablets by mouth	Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration Single dose of PF-07220060 tablets under fasting conditions and under Proton Pump Inhibitor (PPI) administration (following a 7 day oral rabeprazole tablets daily administration). Other Names: Cohort 6, Fasted PPI
Experimental: Treatment G (Cohort 7) Participants will receive PF-07220060 and Rabeprazole tablet by mouth	Drug: Single dose of PF-07220060 as a Tablet formulation under Rabeprazole administration Single dose of PF-07220060 tablets given with high-fat, high-calorie meal and under PPI administration (following a 7 day oral rabeprazole tablets daily administration) Other Names: Cohort 7, Fed PPI

Outcome Measures

Primary Outcome Measures

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 [0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose]
Maximum Observed Plasma Concentration (Cmax) of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations [0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose]

Secondary Outcome Measures

AUCinf of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level [0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose]
Cmax of PF-07220060 to estimate relative bioavailability of PF-07220060 two tablet formulations at a second dose level [0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose]
AUCinf of PF-07220060 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a PF-07220060 tablet formulation [0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose]
Cmax of PF-07220060 to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a PF-07220060 tablet formulation [0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose]
AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition [0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose]
Cmax of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fasted condition [0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose]
AUCinf of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition [0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose]
Cmax of PF-07220060 to estimate the effect of a PPI (rabeprazole) on the bioavailability of a PF-07220060 tablet formulation under fed condition [0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours PF-07220060 post-dose]
Number of Participants With Laboratory Abnormalities [From baseline up to 28 days after PF-07220060 dose]
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings [From baseline up to 28 days after PF-07220060]
Number of Participants With Clinically Significant Change From Baseline in Vital Signs [From baseline up to 28 days after PF-07220060]
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [From baseline up to 28 days after PF-07220060 dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.