A Study for Multiple Tablet Forms of The Study Medicine (PF-07220060) in Healthy Adults
NCT ID: NCT05923411
Last Updated: 2024-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
113 participants
INTERVENTIONAL
2023-07-11
2024-07-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1
Participants will receive PF-07220060 tablet by mouth
Single dose of PF-07220060 as first Tablet Formulation
A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions.
Cohort 2
Participants will receive PF-07220060 tablet by mouth
Single dose of PF-07220060 as second Tablet Formulation
A single dose of PF-0720060 as the second Tablet Formulation administered under fasting conditions
Cohort 3
Participants will receive PF-07220060 tablet by mouth
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
Cohort 4
Participants will receive PF-07220060 tablet by mouth
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
Cohort 5
Participants will receive PF-07220060 tablet by mouth
Single dose of PF-07220060 as a Tablet Formulation
A single dose of PF-07220060 as a tablet formulation administered under fed conditions
Cohort 6
Participants will receive PF-07220060 and Rabeprazole tablets by mouth
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).
Cohort 7
Participants will receive PF-07220060 and Rabeprazole tablet by mouth
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)
Cohort 8
Participants will receive PF-07220060 tablet by mouth
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
Interventions
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Single dose of PF-07220060 as first Tablet Formulation
A single dose of PF-07220060 as the first Tablet Formulation administered under fasting conditions.
Single dose of PF-07220060 as second Tablet Formulation
A single dose of PF-0720060 as the second Tablet Formulation administered under fasting conditions
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
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
Single dose of PF-07220060 as a Tablet Formulation
A single dose of PF-07220060 as a tablet formulation administered under fed conditions
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).
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)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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New Haven Clinical Research Unit
New Haven, Connecticut, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4391007
Identifier Type: -
Identifier Source: org_study_id
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