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Healthy AdultsPhase 1NCT07127770

A Study to Understand How the Body Processes [14C]PF-07104091 in Healthy Participants

A Phase 1 study testing PF-07104091 in people with Healthy Adults, 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.

Official record
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Trial summary

The purpose of this study is to learn how the body processes the study medicine PF-07104091. The study is seeking participants who are: Healthy male aged 18 to 65 years of age Participants in the study will receive 14C-labeled PF-07104091 by mouth after a meal. 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 Adults
What is being tested?
PF-07104091
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteNetherlands
Study dates
28 Aug 2025to 7 Nov 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
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead ECGs.
  • Body mass index (BMI) of 17.5-32.0 kg/m2 inclusive and a total body weight >50 kg (110 lb)
  • Evidence of a personally signed and dated Informed Consent Document (ICD) indicating that the participant has been informed of all pertinent aspects of the study.
  • Participants who are 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, Fixed Sequence, 2-period Study in Healthy Adult Male Participants to Assess the Mass Balance, Absolute Bioavailability, Fraction Absorbed, and Pharmacokinetics of [ 14C]PF-07104091

The purpose of this study is to learn how the body processes the study medicine PF-07104091.

The study is seeking participants who are:

Read more
  • Healthy male aged 18 to 65 years of age

Participants in the study will receive 14C-labeled PF-07104091 by mouth after a meal. After 14 days, the participants will receive PF-07104091 by mouth (after a meal) followed by IV fusion (given directly into a vein) of microdose [14C]PF-07104091.

The study will help understand how the body processes study medicine PF-07104091 and how the medicine is changed and removed from the body after you take it. This study will also help to understand how much PF-07104901 is taken up into the blood.

Participants will remain in the study clinic for a maximum of 23 days and will have one follow-up contact.

Conditions
Healthy Adults
Being tested
PF-07104091
Keywords
Pharmacokinetics, Healthy Volunteers, Biological Availability, Absorption, Elimination, Distribution, ADME, Bioavailability, Radiolabeled, Metabolic Profile, Renal Elimination, Mass Balance, Small molecule, Absolute Bioavailability

What participants receive

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

  • PF-07104091Drug

    Cyclin-dependent kinase-2 inhibitor

Study groups in NCT07127770
Study groupRoleWhat they receive
Regimen A; Period 1ExperimentalSingle oral dose of 14C-labeled PF-07104091 administered under fed conditions.
Receives: Drug: PF-07104091
Regimen B; Period 2ExperimentalSingle oral dose of unlabeled PF-07104091 administered under fed conditions followed by an intravenous (IV) infusion of PF-07104091 containing a microdose of 14C-labeled PF-07104091.
Receives: Drug: PF-07104091

What is being measured

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

  1. Percentage of Total Radiocarbon (14c) excreted in urine

    Percentage of 14C excreted in urine following 14C PF-07104091 single dose administration will be determined as: (Total 14C urine/ 14C dose administered) *100 where, 14C dose was administered dose of 14C PF-07104091.

    Measured: From Predose up to 14 days post dose of period 1 and 2

  2. Percentage of Total Radiocarbon (14c) excreted in feces

    Percentage of 14C excreted in feces following 14C PF-07104091 single dose administration will be determined as: (Total 14C feces/ 14C dose administered) *100 where, 14C dose was administered dose of 14C PF-07104091.

    Measured: From Predose up to 14 days post dose of period 1 (and if applicable for Period 2)

  3. Percentage of Total Radiocarbon (14c) excreted in vomitus (if applicable)

    Percentage of 14C excreted in vomitus (if applicable) following 14C PF-07104091 single dose administration will be determined as: (Total 14C vomitus/ 14C dose administered) *100 where, 14C dose was administered dose of 14C PF-07104091.

    Measured: From Predose up to 14 days post dose of period 1 only

  4. Cumulative Percent Recovery of Total Radiocarbon (14C)

    Percentage recovery of total radioactivity (14C) in urine, feces, and vomitus (If applicable) was determined based on total administered dose.

    Measured: From Predose up to 14 days post dose of period 1 only

  5. Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07104091

    The percentage of major metabolites detected in plasma after oral administration of PF-07104091

    Measured: From Predose to 14 days post dose of period 1

  6. Percentage of Metabolite Detected in Urine After Oral Administration of PF-07104091

    The percentage of major metabolites detected in urine after oral administration of PF-07104091

    Measured: From Predose to 14 days post dose of period 1

  7. Percentage of Metabolite Detected in Feces After Oral Administration of PF-07104091

    The percentage of major metabolites detected in feces after oral administration of PF-07104091

    Measured: From Predose to 14 days post dose of period 1

Secondary outcomes (6)

  1. Oral Absolute Bioavailability

    Dose normalized AUCinf (AUCinf[dn]) will be calculated as AUCinf/Dose, where AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Absolute oral bioavailability is defined as the ratio of geometric mean of AUCinf(dn) following orally administered PF-07104091 (i.e., unlabeled PF-07104091) to AUCinf(dn) following intravenously administered [14C]PF-07104091 in period 2.

    Measured: From Predose up to 14 days post dose, period 2 only.

  2. Fraction of PF-07104091 Dose Absorbed (Fa)

    Fraction of dose absorbed (Fa) will be estimated as the ratio of total or partial radioactivity (dose normalized) excreted into the urine (from time 0 to the time of last measurable concentration) following oral and IV administration of [14C]PF-07104091 microtracer dose in Period 1 and 2, respectively.

    Measured: From Predose up to 14 days post dose

  3. Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters

    Measured: From baseline up to 35 days after the last dose of study intervention (up to Day 36)

  4. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Measured: From baseline up to 35 days after the last dose of study intervention (up to Day 36)

  5. Number of Participants With Clinically Significant Abnormalities in Vital Signs

    Measured: From baseline up to 35 days after the last dose of study intervention (up to Day 36)

  6. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

    Measured: From baseline up to 35 days after the last dose of study intervention (up to Day 36)

Timeline

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

  1. First posted17 Aug 2025
  2. Study start28 Aug 2025
  3. Primary completion8 Oct 2025
  4. Study completion7 Nov 2025

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07127770
Sponsor's protocol ID
C4161006
Other IDs
2024-518696-65-00
Status last verified
Dec 2025
First submitted
1 Jul 2025
Last updated
19 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07104091 in people with Healthy Adults, 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 19 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?

Percentage of Total Radiocarbon (14c) excreted in urine (time frame: From Predose up to 14 days post dose of period 1 and 2). The study lists 7 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 NCT07127770.

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 19 Dec 2025.

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