A Study to Understand How the Body Processes [14C]PF-07104091 in Healthy Participants
NCT ID: NCT07127770
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2025-08-28
2025-11-07
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Regimen A; Period 1
Single oral dose of 14C-labeled PF-07104091 administered under fed conditions.
PF-07104091
Cyclin-dependent kinase-2 inhibitor
Regimen B; Period 2
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.
PF-07104091
Cyclin-dependent kinase-2 inhibitor
Interventions
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PF-07104091
Cyclin-dependent kinase-2 inhibitor
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
65 Years
MALE
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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ICON
Groningen, , Netherlands
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2024-518696-65-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4161006
Identifier Type: -
Identifier Source: org_study_id