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

No results posted yet for this study

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

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

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05923411 on ClinicalTrials.gov