HealthyPhase 1NCT07009353

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

A Phase 1 study testing PF-07054894 in people with Healthy, run by Pfizer at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PF-07054894
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteNetherlands
Study dates: 20 Jun 2025to 11 Sep 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

ICON
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A PHASE 1, OPEN-LABEL, 2-ARM PARALLEL STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF PF-07054894 USING 2 14C-RADIOLABELED PF-07054894 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07054894 IN HEALTHY ADULT MALE PARTICIPANTS USING A 14C-MICROTRACER APPROACH

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.

Read the detailed 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.

Conditions: Healthy
Being tested: PF-07054894

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-07054894Drug
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.
PF-07054894Drug
Cohort 2 Period 1 - Oral [Methyl-14C]PF-07054894 under fasted state.

Study groups in NCT07009353
Study group	Role	What they receive
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). Receives: 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. Receives: Drug: PF-07054894

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14
Metabolite identification/profiling in feces, plasma and urine
Measured: 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.
Measured: 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).
Dose normalized area under the plasma concentration-time profile from time zero extrapolated to infinite time following administration of a single intravenous dose of radiolabeled PF-07054894.
Measured: Period 2 Cohort 1 pre-dose to maximum Day 7
The fraction of PF-07054894 dose absorbed (Fa).
Fa calculated from the ratio of total recovered radioactivity [14C] in urine following single dose administration of [14C]PF-07054894 orally in Period 2 Cohort 1
Measured: Period 2 Cohort 1 pre-dose to maximum Day 7
The absolute oral bioavailability (F) of PF-07054894.
The ratio of dose-normalized plasma AUCinf of oral PF-07054894 and IV administration of [14C]PF-07054894 in Period 2 (Cohort 1).
Measured: 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
Measured: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Number of participants with treatment emergent clinically significant abnormal ECG measurements
Measured: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Number of participants with treatment emergent clinically significant abnormal vital measurements
Measured: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Measured: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Maximum Observed Plasma Concentration (Cmax) of PF-07054894
Measured: Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose
Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) of PF-07054894
Measured: Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07054894
Measured: Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 202511 Sep 2025

First posted6 Jun 2025
Study start20 Jun 2025
Primary completion20 Aug 2025
Study completion11 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Parallel Assignment
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07009353
Sponsor's protocol ID: C4151008
Other IDs: 2024-519882-23-00
Status last verified: Nov 2025
First submitted: 5 May 2025
Last updated: 2 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, 2-ARM PARALLEL STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF PF-07054894 USING 2 14C-RADIOLABELED PF-07054894 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07054894 IN HEALTHY ADULT MALE PARTICIPANTS USING A 14C-MICROTRACER APPROACH
ClinicalTrials.gov ID: NCT07009353
Acronym / sponsor ID: C4151008
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 20 Jun 2025 (actual)
Primary completion: 20 Aug 2025 (actual)
Study completion: 11 Sep 2025 (actual)
First posted: 6 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Parallel Assignment

Arm	Type	Receives
Cohort 1 Period 1 and Period 2	Experimental	Drug: PF-07054894Period 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).
Cohort 2 Period 1	Experimental	Drug: PF-07054894This 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.

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-07054894Cohort 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.	Drug	Cohort 1 Period 1 and Period 2
PF-07054894Cohort 2 Period 1 - Oral [Methyl-14C]PF-07054894 under fasted state.	Drug	Cohort 2 Period 1

Primary outcome

Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered.
Time frame: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14
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).
Metabolite identification/profiling in feces, plasma and urine
Time frame: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14

11 secondary outcomes

Cumulative recovery (%) of radioactivity in plasma expressed as a percent of total oral radioactive dose administered.
Time frame: 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).
Time frame: Period 2 Cohort 1 pre-dose to maximum Day 7
The fraction of PF-07054894 dose absorbed (Fa).
Time frame: Period 2 Cohort 1 pre-dose to maximum Day 7
The absolute oral bioavailability (F) of PF-07054894.
Time frame: 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
Time frame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Number of participants with treatment emergent clinically significant abnormal ECG measurements
Time frame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Number of participants with treatment emergent clinically significant abnormal vital measurements
Time frame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Maximum Observed Plasma Concentration (Cmax) of PF-07054894
Time frame: Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose
Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) of PF-07054894
Time frame: Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07054894
Time frame: Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07054894 in people with Healthy, run by Pfizer at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered. (time frame: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07009353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.