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

Not Applicable

Not yet recruiting

• Conditions: Healthy Adults
• Interventions: Drug: PF-07104091

• Registration Number: NCT07127770
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-01
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Study Start: 2025-08-28
• Primary Completion: 2025-11-05
• Study Completion: 2025-11-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regimen A; Period 1	PF-07104091	Single oral dose of 14C-labeled PF-07104091 administered under fed conditions.
Regimen B; Period 2	PF-07104091	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Total Radiocarbon (14c) excreted in feces	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.
Percentage of Total Radiocarbon (14c) excreted in vomitus (if applicable)	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.
Cumulative Percent Recovery of Total Radiocarbon (14C)	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.
Percentage of Metabolite Detected in Feces After Oral Administration of PF-07104091	From Predose to 14 days post dose of period 1	The percentage of major metabolites detected in feces after oral administration of PF-07104091
Percentage of Total Radiocarbon (14c) excreted in urine	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.
Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07104091	From Predose to 14 days post dose of period 1	The percentage of major metabolites detected in plasma after oral administration of PF-07104091
Percentage of Metabolite Detected in Urine After Oral Administration of PF-07104091	From Predose to 14 days post dose of period 1	The percentage of major metabolites detected in urine after oral administration of PF-07104091

Secondary Outcome Measures

Name	Time	Method
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)
Oral Absolute Bioavailability	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.
Fraction of PF-07104091 Dose Absorbed (Fa)	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.
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)
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	From baseline up to 35 days after the last dose of study intervention (up to Day 36)

Trial Locations

Locations (1)

ICON; 🇳🇱 Groningen, Netherlands