A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Oral PF-07220060; Drug: IV [14C] PF-07220060; Drug: Oral [14C]PF-07220060

Study type: Interventional

Funder types: Industry

Identifiers

NCT06267963

C4391010

2023-507074-40-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Eligibility criteria for this study include, but are not limited to the following:

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: Oral [14C]PF-07220060

Cohort 2

Experimental group

Description:

Participants will take one dose of PF-07220060 by mouth and one dose as an IV (intravenous) infusion of \[14C\] PF-07220060.

Treatment:

Drug: IV [14C] PF-07220060

Drug: Oral PF-07220060