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NCT Number: NCT07508228

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral [14C]PF-07328948

Drug

A single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension in Period 1 and in Period 4 (optional)

Oral Unlabeled PF-07328948

Drug

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)

IV [14C]PF-07328948

Drug

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.

Primary outcomes

  1. 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.

    Time frame: Period 1 pre-dose to maximum Days 22

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events

    Time frame: From baseline and through 28 to 35 days post last study intervention dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Jul 20, 2026

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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