A Study to Understand How a Study Medicine Called PF-07328948 is Absorbed and Processed in the Body of Healthy Male Adults

A PHASE 1, OPEN-LABEL, 4-PERIOD, FIXED-SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION OF [14C]PF-07328948 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07328948 IN HEALTHY MALE ADULT PARTICIPANTS USING A [14C]-MICROTRACER APPROACH

The purpose of this study is to learn how a certain amount of [14C] PF-07320948 is taken up into the bloodstream and removed from the body.

This study is seeking participants who are:

• Male between 18 to 64 years of age
• Deemed to be healthy

This is a 2 Part, 4 Period study where Part 1 has Periods 1 and 2 and Part 2, which is optional, has Periods 3 and 4.

Part 1

• Period 1: The purpose is to see how much of the study medicine PF-07328948 gets into and leaves the body.
• Period 2: The goal is to compare how much PF-07328948 is available in the body when taken by mouth versus by injection into the blood.

Part 2 (Optional)

• Period 3 (optional): If needed, the purpose is to see how PF-07328948 acts after taking it daily until the body reaches a steady level.
• In Period 4 (optional), the goal is to check again how much PF-07328948 is absorbed and leaves the body after daily dosing.

During study clinic stays and study visits, the study team will collect urine and blood samples and perform safety reviews. If only Part 1 is conducted, total time in the study (screening (start) through follow-up (end)) will be about 14 weeks. If both Part 1 and Part 2 are conducted, total time in the study will be about 22 weeks.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Oral [14C]PF-07328948; Drug: Oral Unlabeled PF-07328948; Drug: IV [14C]PF-07328948

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Recruiting
      • Fortrea Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria

• Male participants aged ≥18 years to <65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
• BMI of 17.5-32 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
• Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
• Background radioactivity measured in plasma and/or urine at screening exceeding an F14C value of 2.5.
• Prior participation in a radiolabeled ADME clinical study within 12 months prior to screening.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 1/Treatment A; Participants will receive a single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension.	Drug: Oral [14C]PF-07328948; A single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension in Period 1 and in Period 4 (optional)
Experimental: Period 2/Treatment B; Participants will receive a single tablet of unlabeled oral dose of PF-07328948; ~ 3 hours post-dose, participants will receive a single IV infusion of [14C]PF-07328948	Drug: Oral Unlabeled PF-07328948; A single unlabeled oral dose of PF-07328948 administered as a tablet. Approximately 3 hours post-dose, participants will receive a single IV infusion of [14C]PF-07328948 Period 2: single dose, Period 3: QD Period 4: (Day 2 - mass balance completion); Drug: IV [14C]PF-07328948; A single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 administered as tablets.
Experimental: Period 3/Treatment C; Participants will receive unlabeled tablet oral doses of PF-07328948 once daily for 9 days up to 1 month	Drug: Oral Unlabeled PF-07328948; A single unlabeled oral dose of PF-07328948 administered as a tablet. Approximately 3 hours post-dose, participants will receive a single IV infusion of [14C]PF-07328948 Period 2: single dose, Period 3: QD Period 4: (Day 2 - mass balance completion)
Experimental: Period 4/Treatment D; Participants will receive a single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 tablets	Drug: Oral [14C]PF-07328948; A single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension in Period 1 and in Period 4 (optional)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total recovery of radioactivity in urine, feces, expired air (if analyzed and if reportable), and emesis (if any), and all routes combined, expressed as a percentage of oral radioactive dose administered.	Period 1 pre-dose to maximum Days 22

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment Emergent Adverse Events	From baseline and through 28 to 35 days post last study intervention 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): April 3, 2026
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): September 24, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: C4921009

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