Healthy
Conditions
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.
Interventions
DRUGPF-07054894
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.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Open Label
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered. | 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). |
| Metabolite identification/profiling in feces, plasma and urine | Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The fraction of PF-07054894 dose absorbed (Fa). | 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 |
| The absolute oral bioavailability (F) of PF-07054894. | 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). |
| Number of participants with treatment emergent clinically significant laboratory abnormalities | From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2 | — |
| Number of participants with treatment emergent clinically significant abnormal ECG measurements | From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2 | — |
| Cumulative recovery (%) of radioactivity in plasma expressed as a percent of total oral radioactive dose administered. | Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14 | — |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2 | — |
| Maximum Observed Plasma Concentration (Cmax) of PF-07054894 | 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 | — |
| Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) of PF-07054894 | 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 to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07054894 | 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 | — |
| Number of participants with treatment emergent clinically significant abnormal vital measurements | From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2 | — |
| Dose normalized AUCinf of intravenous radiolabeled PF-07054894 in plasma (if data permit). | 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. |
Countries
Netherlands
Outcome results
None listed