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

NCT07009353 | Completed Phase 1 FDA Drug

• 2 other identifiers: C41510082024-519882-23-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered.

  To characterize the rate and extent of excretion of total radioactivity following administration of a single oral dose of \[14C\]PF-07054894(Period 1 of Cohort 1 \& 2).

  Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14

• Metabolite identification/profiling in feces, plasma and urine

  Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14

Secondary Outcomes (11)

• Cumulative recovery (%) of radioactivity in plasma expressed as a percent of total oral radioactive dose administered.

  Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14

• Dose normalized AUCinf of intravenous radiolabeled PF-07054894 in plasma (if data permit).

  Period 2 Cohort 1 pre-dose to maximum Day 7

• The fraction of PF-07054894 dose absorbed (Fa).

  Period 2 Cohort 1 pre-dose to maximum Day 7

• The absolute oral bioavailability (F) of PF-07054894.

  Period 1 of Cohort 1 pre-dose to maximum Day 14 and Period 2 Cohort 1 pre-dose to maximum Day 7

• Number of participants with treatment emergent clinically significant laboratory abnormalities

  From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2

Study Arms (2)

Cohort 1 Period 1 and Period 2

EXPERIMENTAL

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).

Drug: PF-07054894

Cohort 2 Period 1

EXPERIMENTAL

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.

Drug: PF-07054894

Interventions

PF-07054894 DRUG

Cohort 1 Period 1 - Oral \[cyclobutenyl-14C\]PF-07054894 under fasted state. Cohort 1 Period 2: Oral unlabeled PF-07054894 followed by IV \[cyclobutenyl-14C\]PF-07054894 fusion over approximately 15 minutes at approximately 1.5 hours after the administration of the oral unlabeled dose. Cohort 1 Period 2: Oral unlabeled PF-07054894 followed by IV \[cyclobutenyl-14C\]PF-07054894 fusion over approximately 15 minutes at approximately 1.5 hours after the administration of the oral unlabeled dose.

Cohort 1 Period 1 and Period 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only Male participants aged 18 years to 65 years inclusive (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

ICON

Groningen, 9728 NZ, Netherlands

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 6, 2025
• Study Start: June 20, 2025
• Primary Completion: August 20, 2025
• Study Completion: September 11, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)