Clinical trial NCT06267963: A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults
Official title: A PHASE 1, OPEN-LABEL, PARALLEL-GROUP, SINGLE-DOSE STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C]-PF-07220060 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07220060 USING A 14C-MICROTRACER APPROACH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Absorption
Distribution
Metabolism
Elimination
ADME (Absorption, Distribution, Metabolism and Excretion)
Pharmacokinetics
Bioavailability
Fraction absorbed
Mass balance
Healthy Males
Cyclin-Dependent Kinase 4 (CDK4) inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.

The study is seeking for participants who:

* are males aged 18 to 65 years and are healthy.
* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
* have a total body weight of at least 50 kilograms.

The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.

In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.

During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up.


Eligibility criteria: Key Eligibility criteria for this study include, but are not limited to the following:

Inclusion Criteria:

* Male participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Body mass index (BMI) of 17.5-30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria:

* Participants with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome \[IBS\] or lactose intolerance).
* Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
* Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.

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: Cohort 1 pre-dose to maximum Day 14
measure: Amount of metabolites of [14C]PF-07220060 in plasma, urine, and feces.
timeFrame: Cohort 1 pre-dose to maximum Day 14
Secondary outcomes:
measure: Dose normalized AUCinf of intravenous radiolabeled PF-07220060 in plasma (if data permit)
timeFrame: Cohort 2 pre-dose to maximum Day 14
measure: The absolute oral bioavailability (F) of PF-07220060
timeFrame: Cohort 2 pre-dose to maximum Day 14
measure: The fraction of PF-07220060 dose absorbed (Fa)
timeFrame: Cohort 1 predose to maximum Day 14; Cohort 2 pre-IV dose to maximum Day 14
measure: Number of participants with treatment emergent clinically significant laboratory abnormalities
timeFrame: Both cohorts from pre-dose to 28 days post-dose
measure: Number of participants with treatment emergent clinically significant abnormal ECG measurements
timeFrame: Both cohorts from pre-dose to 28 days post-dose
measure: Number of participants with treatment emergent clinically significant abnormal vital measurements
timeFrame: Both cohorts from pre-dose to 28 days post-dose
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Both cohorts from pre-dose to 28 days post-dose
measure: Number of participants with treatment emergent clinically significant abnormal physical examination
timeFrame: Both cohorts from pre-dose to 28 days post-dose
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: