ICON
Groningen, 9728 NZ, Netherlands
NCT Number: NCT07009353
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.
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Notify Me18 year–65 year
Male
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
There are two groups in this study:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Cohort 1 Period 1 - Oral [cyclobutenyl-14C]PF-07054894 under fasted state. Cohort 1 Period 2: Oral unlabeled PF-07054894 followed by IV [cyclobutenyl-14C]PF-07054894 fusion over approximately 15 minutes at approximately 1.5 hours after the administration of the oral unlabeled dose.
Cohort 1 Period 2: Oral unlabeled PF-07054894 followed by IV [cyclobutenyl-14C]PF-07054894 fusion over approximately 15 minutes at approximately 1.5 hours after the administration of the oral unlabeled dose.
Time frame: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14
To characterize the rate and extent of excretion of total radioactivity following administration of a single oral dose of [14C]PF-07054894(Period 1 of Cohort 1 & 2).
Time frame: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14
Time frame: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14
Time frame: Period 2 Cohort 1 pre-dose to maximum Day 7
Dose normalized area under the plasma concentration-time profile from time zero extrapolated to infinite time following administration of a single intravenous dose of radiolabeled PF-07054894.
Time frame: Period 2 Cohort 1 pre-dose to maximum Day 7
Fa calculated from the ratio of total recovered radioactivity [14C] in urine following single dose administration of [14C]PF-07054894 orally in Period 2 Cohort 1
Time frame: Period 1 of Cohort 1 pre-dose to maximum Day 14 and Period 2 Cohort 1 pre-dose to maximum Day 7
The ratio of dose-normalized plasma AUCinf of oral PF-07054894 and IV administration of [14C]PF-07054894 in Period 2 (Cohort 1).
Time frame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Time frame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Time frame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Time frame: From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2
Time frame: 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
Time frame: 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
Time frame: 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
Pfizer
Industry
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
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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