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NCT Number: NCT07578636

A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Healthy Adults

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Male Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

About this study

Not Provided.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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).

Exclusion criteria

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.

Treatment and study plan

Oral [14C] PF-07799544

Drug

A single oral dose of [14C] PF-07799544 will be administered as an extemporaneous suspension in Period 1.

Oral Unlabeled PF-07799544

Drug

A single oral dose of unlabeled PF-07799544 will be administered as extemporaneous solution in Period 2.

IV [14C] PF-07799544

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    To determine the fraction of PF-07799544 dose absorbed (Fa) from a single oral dose of [14C]PF-07799544.

  3. Number of Participants With Treatment Emergent Adverse Events.

    Time frame: Baseline up to 28 to 35 days post last study intervention dose.

    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.

  4. Number of Participants with Treatment Emergent Clinically Significant Laboratory Abnormalities.

    Time frame: Baseline up to 28 to 35 days post last study intervention dose.

    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.

  5. 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.

    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.

  6. 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.

    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.

  7. 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.

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 11, 2026
Registry last updated
Jul 28, 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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