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

NCT07508228 | Recruiting Phase 1 FDA Drug

• 1 other identifier: C4921009
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

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.

  Period 1 pre-dose to maximum Days 22

Secondary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events

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

Study Arms (4)

Period 1/Treatment A

EXPERIMENTAL

Participants will receive a single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension.

Drug: Oral [14C]PF-07328948

Period 2/Treatment B

EXPERIMENTAL

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; Drug: IV [14C]PF-07328948

Period 3/Treatment C

EXPERIMENTAL

Participants will receive unlabeled tablet oral doses of PF-07328948 once daily for 9 days up to 1 month

Drug: Oral Unlabeled PF-07328948

Period 4/Treatment D

EXPERIMENTAL

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

Interventions

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)

Period 1/Treatment A; Period 4/Treatment D

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)

Period 2/Treatment B; Period 3/Treatment C

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.

Period 2/Treatment B

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: This study is seeking participants who are: * Male between 18 to 64 years of age * Deemed to be healthy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

RECRUITING

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)