Clinical trial NCT07009353: A Study to Learn How the Study Medicine Called [14C]PF-07054894 is Processed by the Body
Official title: A PHASE 1, OPEN-LABEL, 2-ARM PARALLEL STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF PF-07054894 USING 2 14C-RADIOLABELED PF-07054894 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07054894 IN HEALTHY ADULT MALE PARTICIPANTS USING A 14C-MICROTRACER APPROACH
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn how quickly and to what extent the study medicine (PF-07054894) is absorbed, broken down, and eliminated from the body.

Detailed description: There are two groups in this study:

* Cohort 1 (which has 2 periods)
* Cohort 2 (has 1 period) Participants will only have to participate in one of the 2 Cohorts.
* In Cohort 1 - Period 1, the study will check how the study medicine (PF-07054894) is removed from the body. In Period 2, the study will find out how well the study medicine is absorbed by the body when given by mouth compared to an intravenous route. (solution of the study medicine is injected directly into a vein). For this period, the PF-07054894 that is injected into the vein is radioactively labeled, but the dose given by mouth is not radioactively labeled. Radioactively labelled are compounds where one or more atoms have been replaced with a radioactive element. This allows researchers to track their movement within cells.
* In Cohort 2 - a different radioactive labelled material is used than the one of Cohort 1. This is done to see how PF 07054894 is removed from the body. The study will also look at how safe the study medicine is and how well it is tolerated when it is given to healthy people.

Participants in Cohort 1 will be involved in this study for about 10 weeks and about 8 weeks for those in Cohort 2. Participants in Cohort 1 will stay in the study clinic in Period 1 for up to 15 days (14 nights) and 8 days (7 nights) in Period 2. Participants in Cohort 2 will stay in the study clinic for up to 15 days (14 nights).

For Period 1 of both Cohort 1 and 2, the study doctor will be checking the levels of radioactively labeled study medicine in body frequently from Day 7 onwards in urine, stool, and any vomit and will let participants know as soon as possible if they have to stay longer or if they can go home. The duration of participants' stay will depend on how quickly or slowly the radioactively labeled study compound leaves their body.

For Period 2, participants will have to stay in the study clinic for 8 days (7 nights) and leave the study clinic on Day 7. However, if the study doctor believes it is necessary to protect participant's health, they may be asked to remain in the study clinic after Day 7.

Eligibility criteria: 1. Healthy male, aged 18 years to 65 years at screening.
2. Body mass index (BMI) of about 18 to 32 kilogram per meter squared, and a total body weight greater than 50 kilograms (110 pounds).
3. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Primary outcomes:
measure: Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered.
timeFrame: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14
measure: Metabolite identification/profiling in feces, plasma and urine
timeFrame: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14
Secondary outcomes:
measure: Cumulative recovery (%) of radioactivity in plasma expressed as a percent of total oral radioactive dose administered.
timeFrame: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14
measure: Dose normalized AUCinf of intravenous radiolabeled PF-07054894 in plasma (if data permit).
timeFrame: Period 2 Cohort 1 pre-dose to maximum Day 7
measure: The fraction of PF-07054894 dose absorbed (Fa).
timeFrame: Period 2 Cohort 1 pre-dose to maximum Day 7
measure: The absolute oral bioavailability (F) of PF-07054894.
timeFrame: Period 1 of Cohort 1 pre-dose to maximum Day 14 and Period 2 Cohort 1 pre-dose to maximum Day 7
measure: Number of participants with treatment emergent clinically significant laboratory abnormalities
timeFrame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
measure: Number of participants with treatment emergent clinically significant abnormal ECG measurements
timeFrame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
measure: Number of participants with treatment emergent clinically significant abnormal vital measurements
timeFrame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
measure: Maximum Observed Plasma Concentration (Cmax) of PF-07054894
timeFrame: Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose
measure: Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) of PF-07054894
timeFrame: Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07054894
timeFrame: Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: