A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Oral [14C]PF-07220060; Drug: IV [14C] PF-07220060; Drug: Oral PF-07220060

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants will receive one dose of [14C] PF-07220060 by mouth	Drug: Oral [14C]PF-07220060; A single oral dose of [14C]PF-07220060, will be administered as a liquid formulation in Cohort 1.
Experimental: Cohort 2; Participants will take one dose of PF-07220060 by mouth and one dose as an IV (intravenous) infusion of [14C] PF-07220060.	Drug: IV [14C] PF-07220060; A single IV infusion of [14C]PF-07220060 will be administered in Cohort 2 at Tmax after the administration of the unlabeled oral dose.; Drug: Oral PF-07220060; A single oral dose of PF-07220060, will be administered as a liquid formulation in Cohort 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered.	To characterize the rate and extent of excretion of total radioactivity following administration of a single oral dose of [14C]PF-07220060.	Cohort 1 pre-dose to maximum Day 14
Amount of metabolites of [14C]PF-07220060 in plasma, urine, and feces.	To characterize the metabolic profile for PF- 07220060 and identify the circulating and excreted metabolites of PF-07220060 following administration of a single oral dose of [14C]PF-07220060.	Cohort 1 pre-dose to maximum Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose normalized AUCinf of intravenous radiolabeled PF-07220060 in plasma (if data permit)	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-07220060.	Cohort 2 pre-dose to maximum Day 14
The absolute oral bioavailability (F) of PF-07220060	The ratio of dose-normalized plasma AUCinf of oral PF-07220060 and IV [14C]PF-07220060	Cohort 2 pre-dose to maximum Day 14
The fraction of PF-07220060 dose absorbed (Fa)	Fa calculated from the ratio of total recovered radioactivity [14C] in urine following single dose administration of [14C]PF-07220060 orally in Cohort 1 and via IV infusion in Cohort 2.	Cohort 1 predose to maximum Day 14; Cohort 2 pre-IV dose to maximum Day 14
Number of participants with treatment emergent clinically significant laboratory abnormalities		Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal ECG measurements		Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal vital measurements		Both cohorts from pre-dose to 28 days post-dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)		Both cohorts from pre-dose to 28 days post-dose
Number of participants with treatment emergent clinically significant abnormal physical examination		Both cohorts from pre-dose to 28 days post-dose

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Actual): April 12, 2024
• Study Completion (Actual): April 12, 2024

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Estimated): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Bioavailability; Distribution; Absorption; Metabolism; Elimination; Mass balance; Fraction absorbed; Healthy Males; Cyclin-Dependent Kinase 4 (CDK4) inhibitor; ADME (Absorption, Distribution, Metabolism and Excretion)
• Other Study ID Numbers: C4391010; 2023-507074-40-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No