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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-04-12

Brief Summary

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The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.

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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1

Participants will receive one dose of \[14C\] PF-07220060 by mouth

Group Type EXPERIMENTAL

Oral [14C]PF-07220060

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Oral PF-07220060

Intervention Type DRUG

A single oral dose of PF-07220060, will be administered as a liquid formulation in Cohort 2.

IV [14C] PF-07220060

Intervention Type DRUG

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.

Intervention Type DRUG

Oral PF-07220060

A single oral dose of PF-07220060, will be administered as a liquid formulation in Cohort 2.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* 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

* Participants with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome \[IBS\] or lactose intolerance).
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Netherlands

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4391010

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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