A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults
NCT ID: NCT06267963
Last Updated: 2024-05-14
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
12 participants
INTERVENTIONAL
2024-01-31
2024-04-12
Brief Summary
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The study is seeking for participants who:
* are males aged 18 to 65 years and are healthy.
* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
* have a total body weight of at least 50 kilograms.
The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.
In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.
During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up.
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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 one dose of \[14C\] PF-07220060 by mouth
Oral [14C]PF-07220060
A single oral dose of \[14C\]PF-07220060, will be administered as a liquid formulation in Cohort 1.
Cohort 2
Participants will take one dose of PF-07220060 by mouth and one dose as an IV (intravenous) infusion of \[14C\] PF-07220060.
Oral PF-07220060
A single oral dose of PF-07220060, will be administered as a liquid formulation in Cohort 2.
IV [14C] PF-07220060
A single IV infusion of \[14C\]PF-07220060 will be administered in Cohort 2 at Tmax after the administration of the unlabeled oral dose.
Interventions
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Oral [14C]PF-07220060
A single oral dose of \[14C\]PF-07220060, will be administered as a liquid formulation in Cohort 1.
Oral PF-07220060
A single oral dose of PF-07220060, will be administered as a liquid formulation in Cohort 2.
IV [14C] PF-07220060
A single IV infusion of \[14C\]PF-07220060 will be administered in Cohort 2 at Tmax after the administration of the unlabeled oral dose.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 17.5-30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Exclusion Criteria
* Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
* Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
18 Years
65 Years
MALE
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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PRA Health Sciences
Groningen, , Netherlands
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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2023-507074-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4391010
Identifier Type: -
Identifier Source: org_study_id
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