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

NCT07127770 | Completed Phase 1 FDA Drug

• 2 other identifiers: C41610062024-518696-65-00
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Pharmacokinetics; Healthy Volunteers; Biological Availability; Absorption; Elimination; Distribution; ADME; Bioavailability; Radiolabeled; Metabolic Profile; Renal Elimination; Mass Balance; Small molecule; Absolute Bioavailability

Outcome Measures

Primary Outcomes (7)

• 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.

  From Predose up to 14 days post dose of period 1 and 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.

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

• 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.

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

• 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.

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

• 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

  From Predose to 14 days post dose of period 1

• 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

  From Predose to 14 days post dose of period 1

• 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

  From Predose to 14 days post dose of period 1

Secondary Outcomes (6)

• Oral Absolute Bioavailability

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

• Fraction of PF-07104091 Dose Absorbed (Fa)

  From Predose up to 14 days post dose

• Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters

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

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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

• Number of Participants With Clinically Significant Abnormalities in Vital Signs

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

Study Arms (2)

Regimen A; Period 1

EXPERIMENTAL

Single oral dose of 14C-labeled PF-07104091 administered under fed conditions.

Drug: PF-07104091

Regimen B; Period 2

EXPERIMENTAL

Single 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.

Drug: PF-07104091

Interventions

PF-07104091 DRUG

Cyclin-dependent kinase-2 inhibitor

Regimen A; Period 1; Regimen B; Period 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead ECGs
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

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: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: August 17, 2025
• Study Start: August 28, 2025
• Primary Completion: October 8, 2025
• Study Completion: November 7, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)