A Study to Learn How the Study Medicine Called [14C]PF-07054894 is Processed by the Body

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-07054894

Study type: Interventional

Funder types: Industry

Identifiers

NCT07009353

2024-519882-23-00 (Registry Identifier)

C4151008

Details and patient eligibility

About

The purpose of this study is to learn how quickly and to what extent the study medicine (PF-07054894) is absorbed, broken down, and eliminated from the body.

Full description

There are two groups in this study:

• Cohort 1 (which has 2 periods)
• Cohort 2 (has 1 period) Participants will only have to participate in one of the 2 Cohorts.
• In Cohort 1 - Period 1, the study will check how the study medicine (PF-07054894) is removed from the body. In Period 2, the study will find out how well the study medicine is absorbed by the body when given by mouth compared to an intravenous route. (solution of the study medicine is injected directly into a vein). For this period, the PF-07054894 that is injected into the vein is radioactively labeled, but the dose given by mouth is not radioactively labeled. Radioactively labelled are compounds where one or more atoms have been replaced with a radioactive element. This allows researchers to track their movement within cells.
• In Cohort 2 - a different radioactive labelled material is used than the one of Cohort 1. This is done to see how PF 07054894 is removed from the body. The study will also look at how safe the study medicine is and how well it is tolerated when it is given to healthy people.

Participants in Cohort 1 will be involved in this study for about 10 weeks and about 8 weeks for those in Cohort 2. Participants in Cohort 1 will stay in the study clinic in Period 1 for up to 15 days (14 nights) and 8 days (7 nights) in Period 2. Participants in Cohort 2 will stay in the study clinic for up to 15 days (14 nights).

For Period 1 of both Cohort 1 and 2, the study doctor will be checking the levels of radioactively labeled study medicine in body frequently from Day 7 onwards in urine, stool, and any vomit and will let participants know as soon as possible if they have to stay longer or if they can go home. The duration of participants' stay will depend on how quickly or slowly the radioactively labeled study compound leaves their body.

For Period 2, participants will have to stay in the study clinic for 8 days (7 nights) and leave the study clinic on Day 7. However, if the study doctor believes it is necessary to protect participant's health, they may be asked to remain in the study clinic after Day 7.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Healthy male, aged 18 years to 65 years at screening.
2. Body mass index (BMI) of about 18 to 32 kilogram per meter squared, and a total body weight greater than 50 kilograms (110 pounds).
3. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Cohort 1 Period 1 and Period 2

Experimental group

Description:

Period 1: This is designed to evaluate the metabolic fate and extent of excretion of PF-07054894 following the study drug administration via the intended clinical route of administration (oral) of \[cyclobutenyl-14C\]PF-07054894. In order to assess the metabolic fate of \[14C\]PF-07054894, metabolites of \[14C\]PF-07054894 circulating in plasma and eliminated in urine and feces following oral administration. Period 2: This is designed to evaluate oral bioavailability of a drug and also allow to estimate the fraction of the dose absorbed of the oral PF-07054894 dose. Determination of the fraction of the dose absorbed will provide information on the total PF-07054894 dose absorbed, regardless of the fate of that dose after absorption (eg, metabolism, degradation).

Treatment:

Drug: PF-07054894

Drug: PF-07054894

Cohort 2 Period 1

Experimental group

Description:

This is designed to further evaluate the cleavage of PF-07054894, which was identified in plasma samples from a preliminary investigation of metabolism in the FIH study. The metabolic fate and extent of excretion of PF-07054894 following the study drug administration via the intended clinical route of administration (oral) of - \[methyl-14C\]PF-07054894 will be evaluated.

Treatment:

Drug: PF-07054894

Drug: PF-07054894