HealthyPhase 1NCT07508228

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 study testing Oral [14C]PF-07328948, Oral Unlabeled PF-07328948 and IV [14C]PF-07328948 in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Oral [14C]PF-07328948, Oral Unlabeled PF-07328948 and IV [14C]PF-07328948
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 3 Apr 2026to 10 Jul 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official 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

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
Being tested: Oral [14C]PF-07328948, Oral Unlabeled PF-07328948, IV [14C]PF-07328948

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral [14C]PF-07328948Drug
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-07328948Drug
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-07328948Drug
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.

Study groups in NCT07508228
Study group	Role	What they receive
Period 1/Treatment A	Experimental	Participants will receive a single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension. Receives: Drug: Oral [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 Receives: 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 Receives: 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 Receives: Drug: Oral Unlabeled PF-07328948; Drug: IV [14C]PF-07328948

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Period 1 pre-dose to maximum Days 22

Secondary outcomes (1)

Number of Participants with Treatment Emergent Adverse Events
Measured: From baseline and through 28 to 35 days post last study intervention dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 202610 Jul 2026

First posted2 Apr 2026
Study start3 Apr 2026
Primary completion10 Jul 2026
Study completion10 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07508228
Sponsor's protocol ID: C4921009
Status last verified: Aug 2026
First submitted: 27 Mar 2026
Last updated: 6 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT07508228
Acronym / sponsor ID: C4921009
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 3 Apr 2026 (actual)
Primary completion: 10 Jul 2026 (actual)
Study completion: 10 Jul 2026 (actual)
First posted: 2 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Period 1/Treatment A	Experimental	Drug: Oral [14C]PF-07328948Participants will receive a single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension.
Period 3/Treatment C	Experimental	Drug: Oral Unlabeled PF-07328948Participants will receive unlabeled tablet oral doses of PF-07328948 once daily for 9 days up to 1 month
Period 4/Treatment D	Experimental	Drug: Oral [14C]PF-07328948Participants 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
Period 2/Treatment B	Experimental	Drug: Oral Unlabeled PF-07328948, Drug: IV [14C]PF-07328948Participants 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

Who may qualify

Ages: 18 to 64 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral [14C]PF-07328948A single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension in Period 1 and in Period 4 (optional)	Drug	Period 1/Treatment A, Period 4/Treatment D
Oral Unlabeled PF-07328948A 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	Period 2/Treatment B, Period 3/Treatment C
IV [14C]PF-07328948A 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.	Drug	Period 2/Treatment B

Primary outcome

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

1 secondary outcome

Number of Participants with Treatment Emergent Adverse Events
Time frame: From baseline and through 28 to 35 days post last study intervention dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oral [14C]PF-07328948, Oral Unlabeled PF-07328948 and IV [14C]PF-07328948 in people with Healthy, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07508228.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.