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Completed

NCT Number: NCT07127770

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

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. 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.

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Key information

Conditions

Healthy Adults

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ICON

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

PF-07104091

Drug

Cyclin-dependent kinase-2 inhibitor

Primary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

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

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

    Time frame: From Predose to 14 days post dose of period 1

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

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

    Time frame: From Predose to 14 days post dose of period 1

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

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

    Time frame: From Predose to 14 days post dose of period 1

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

Secondary outcomes

  1. Oral Absolute Bioavailability

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

    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.

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

    Time frame: From Predose up to 14 days post dose

    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.

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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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