Healthy Male VolunteersPhase 1NCT07578636
A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Healthy Adults
A Phase 1 study testing Oral [14C] PF-07799544, Oral Unlabeled PF-07799544 and IV [14C] PF-07799544 in people with Healthy Male Volunteers, run by Pfizer at 1 site in United States.
Trial summary
For this study, the study medicine has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study medicine does not change how the medicine works but helps to see how the medicine appears in the blood… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Oral [14C] PF-07799544, Oral Unlabeled PF-07799544 and IV [14C] PF-07799544
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to 15 Aug 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males 18 to 55years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
- 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.
- Total 14C radioactivity measured in plasma should not exceed 2.5 × standard biological carbon ratio.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-07799544 USING A 14C-MICROTRACER APPROACH
For this study, the study medicine has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study medicine does not change how the medicine works but helps to see how the medicine appears in the blood, urine, and stool after it is given. This type of study is called a radiolabeled study.
The purpose of this radiolabeled study is to learn how a certain amount of [14C] PF-07799544 is taken up into the bloodstream and removed from the body.
Read more
The study is seeking participants who are:
Male Ages 18 to 55 years of age confirmed to be healthy based on medical and physical tests.
Weigh more than 50 kilograms (kg) and have a body mass index of 17.5 to 32 kg per meter squared.
The study consists of two parts. In part one, all participants will receive one full dose of [14C]PF-07799544 by mouth.
Part two will begin at least 14 days after the dose in part one. In part two, participants will receive one full dose of PF-07799544 by mouth and one small dose of [14C] PF-07799544 by intravenous (IV) infusion. IV infusion will be directly injected into the veins.
To understand how the medicine is processed in the body, samples of blood, urine, feces, and vomit (if any) will be collected after each dose is given. This will help understand:
How much PF-07799544 is taken up into the bloodstream when taken by mouth compared to the dose given by IV How the body removes it from the blood steam. Participants will take part in the study for about 7 weeks, including evaluation at the start and follow-up period.
Read the detailed description
Not Provided.
- Conditions
- Healthy Male Volunteers
- Being tested
- Oral [14C] PF-07799544, Oral Unlabeled PF-07799544, IV [14C] PF-07799544
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral [14C] PF-07799544Drug
A single oral dose of [14C] PF-07799544 will be administered as an extemporaneous suspension in Period 1.
Oral Unlabeled PF-07799544Drug
A single oral dose of unlabeled PF-07799544 will be administered as extemporaneous solution in Period 2.
IV [14C] PF-07799544Drug
A single IV infusion of [14C] PF-07799544 will be administered at the approximate Tmax after administration of the unlabeled oral dose of PF-07248144 in Period 2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive one dose of [14C] PF-07799544 by mouth in Period 1. After a washout, participants will receive one dose of PF-07799544 by mouth and one intravenous (IV) infusion of [14C] PF-07799544 in Period 2 Receives: Drug: Oral [14C] PF-07799544; Drug: Oral Unlabeled PF-07799544; Drug: IV [14C] PF-07799544 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery (%) of radioactivity in urine, feces and vomitus (if any), expressed as a percent of total oral radioactive dose administered.
To characterize the extent of excretion of total radioactivity in urine, feces and vomitus (if any) following administration of a single oral dose of [14C]PF-07799544.
Measured: Period 1 pre-dose to maximum days 15
Metabolic profiling/identification and determination of relative abundance of [14C]PF-07799544 and the metabolites of PF-07799544 in plasma, urine and feces, if possible.
To characterize the metabolic profile and identify the circulating and excreted metabolites of PF- 07799544 following administration of a single oral dose of [14C]PF-07799544.
Measured: Period 1 pre-dose to maximum days 15
Secondary outcomes (7)
The ratio of dose-normalized AUCinf (if data permit, otherwise AUClast) of oral PF-07799544 to IV [14C]PF-07799544.
To determine the oral absolute bioavailability (F) of PF-07799544 from a single oral dose of PF-07799544 compared to a single IV microtracer of [14C]PF-07799544.
Measured: Period 2 pre-dose to maximum days 6.
The ratio of total recovered radioactivity 14C in urine following single dose administration of [14C]PF-07799544 orally in Period 1 and IV microtracer, microdose administration of [14C]PF-07799544 in Period 2.
To determine the fraction of PF-07799544 dose absorbed (Fa) from a single oral dose of [14C]PF-07799544.
Measured: Period 1 pre-dose to maximum days 15; Period 2 pre-dose to maximum days 6.
Number of Participants With Treatment Emergent Adverse Events.
To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
Measured: Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants with Treatment Emergent Clinically Significant Laboratory Abnormalities.
To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
Measured: Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants With Treatment Emergent Clinically Significant Abnormal Vital Signs.
To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
Measured: Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants With Treatment Emergent Clinically Significant Physical Examination Abnormalities.
To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
Measured: Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants With Treatment Emergent Clinically Significant Abnormal ECG Measurements.
To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
Measured: Baseline up to 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.
- First posted11 May 2026
- Study start18 May 2026
- Primary completion2 Jul 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- Model description
- Crossover Assignment
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578636
- Sponsor's protocol ID
- C4901004
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 21 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-07799544 USING A 14C-MICROTRACER APPROACH
- ClinicalTrials.gov ID
- NCT07578636
- Acronym / sponsor ID
- C4901004
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 11 May 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.
For this study, the study medicine has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study medicine does not change how the medicine works but helps to see how the medicine appears in the blood, urine, and stool after it is given. This type of study is called a radiolabeled study.
The purpose of this radiolabeled study is to learn how a certain amount of [14C] PF-07799544 is taken up into the bloodstream and removed from the body.
The study is seeking participants who are:
Male Ages 18 to 55 years of age confirmed to be healthy based on medical and physical tests.
Weigh more than 50 kilograms (kg) and have a body mass index of 17.5 to 32 kg per meter squared.
The study consists of two parts. In part one, all participants will receive one full dose of [14C]PF-07799544 by mouth.
Part two will begin at least 14 days after the dose in part one. In part two, participants will receive one full dose of PF-07799544 by mouth and one small dose of [14C] PF-07799544 by intravenous (IV) infusion. IV infusion will be directly injected into the veins.
To understand how the medicine is processed in the body, samples of blood, urine, feces, and vomit (if any) will be collected after each dose is given. This will help understand:
How much PF-07799544 is taken up into the bloodstream when taken by mouth compared to the dose given by IV How the body removes it from the blood steam. Participants will take part in the study for about 7 weeks, including evaluation at the start and follow-up period.
Detailed description
Not Provided.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Oral [14C] PF-07799544, Drug: Oral Unlabeled PF-07799544, Drug: IV [14C] PF-07799544Participants will receive one dose of [14C] PF-07799544 by mouth in Period 1. After a washout, participants will receive one dose of PF-07799544 by mouth and one intravenous (IV) infusion of [14C] PF-07799544 in Period 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males 18 to 55years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECGs.
- BMI of 17.5-32 kg/m2; and a total body weight >50 kg (110 lb).
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
- 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.
- Total 14C radioactivity measured in plasma should not exceed 2.5 × standard biological carbon ratio.
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-07799544A single oral dose of [14C] PF-07799544 will be administered as an extemporaneous suspension in Period 1. | Drug | Cohort 1 |
| Oral Unlabeled PF-07799544A single oral dose of unlabeled PF-07799544 will be administered as extemporaneous solution in Period 2. | Drug | Cohort 1 |
| IV [14C] PF-07799544A single IV infusion of [14C] PF-07799544 will be administered at the approximate Tmax after administration of the unlabeled oral dose of PF-07248144 in Period 2. | Drug | Cohort 1 |
Primary outcome
Total recovery (%) of radioactivity in urine, feces and vomitus (if any), expressed as a percent of total oral radioactive dose administered.
Time frame: Period 1 pre-dose to maximum days 15
To characterize the extent of excretion of total radioactivity in urine, feces and vomitus (if any) following administration of a single oral dose of [14C]PF-07799544.
Metabolic profiling/identification and determination of relative abundance of [14C]PF-07799544 and the metabolites of PF-07799544 in plasma, urine and feces, if possible.
Time frame: Period 1 pre-dose to maximum days 15
To characterize the metabolic profile and identify the circulating and excreted metabolites of PF- 07799544 following administration of a single oral dose of [14C]PF-07799544.
7 secondary outcomes
The ratio of dose-normalized AUCinf (if data permit, otherwise AUClast) of oral PF-07799544 to IV [14C]PF-07799544.
Time frame: Period 2 pre-dose to maximum days 6.
The ratio of total recovered radioactivity 14C in urine following single dose administration of [14C]PF-07799544 orally in Period 1 and IV microtracer, microdose administration of [14C]PF-07799544 in Period 2.
Time frame: Period 1 pre-dose to maximum days 15; Period 2 pre-dose to maximum days 6.
Number of Participants With Treatment Emergent Adverse Events.
Time frame: Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants with Treatment Emergent Clinically Significant Laboratory Abnormalities.
Time frame: Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants With Treatment Emergent Clinically Significant Abnormal Vital Signs.
Time frame: Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants With Treatment Emergent Clinically Significant Physical Examination Abnormalities.
Time frame: Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants With Treatment Emergent Clinically Significant Abnormal ECG Measurements.
Time frame: Baseline up to 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 21 Sep 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.
Related trials for Healthy Male Volunteers
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Not yet recruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 1/2
Vasopressin and Pain Perception in the Brain
Acute Pain
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
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-07799544, Oral Unlabeled PF-07799544 and IV [14C] PF-07799544 in people with Healthy Male Volunteers, 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 3 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 21 Sep 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 and vomitus (if any), expressed as a percent of total oral radioactive dose administered. (time frame: Period 1 pre-dose to maximum days 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.