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

5. maj 2026 opdateret af: Pfizer

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.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Not Provided.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

9

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1
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
Medicin: Oral [14C] PF-07799544
A single oral dose of [14C] PF-07799544 will be administered as an extemporaneous suspension in Period 1.
Medicin: Oral Unlabeled PF-07799544
A single oral dose of unlabeled PF-07799544 will be administered as extemporaneous solution in Period 2.
Medicin: IV [14C] PF-07799544
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total recovery (%) of radioactivity in urine, feces and vomitus (if any), expressed as a percent of total oral radioactive dose administered.
Tidsramme: 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.
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.
Tidsramme: 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.
Period 1 pre-dose to maximum days 15

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The ratio of dose-normalized AUCinf (if data permit, otherwise AUClast) of oral PF-07799544 to IV [14C]PF-07799544.
Tidsramme: 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.
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.
Tidsramme: 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.
Period 1 pre-dose to maximum days 15; Period 2 pre-dose to maximum days 6.
Number of Participants With Treatment Emergent Adverse Events.
Tidsramme: 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.
Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants with Treatment Emergent Clinically Significant Laboratory Abnormalities.
Tidsramme: 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.
Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants With Treatment Emergent Clinically Significant Abnormal Vital Signs.
Tidsramme: 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.
Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants With Treatment Emergent Clinically Significant Physical Examination Abnormalities.
Tidsramme: 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.
Baseline up to 28 to 35 days post last study intervention dose.
Number of Participants With Treatment Emergent Clinically Significant Abnormal ECG Measurements.
Tidsramme: 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.
Baseline up to 28 to 35 days post last study intervention dose.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. maj 2026

Primær færdiggørelse (Anslået)

12. september 2026

Studieafslutning (Anslået)

12. september 2026

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • C4901004

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sunde mandlige frivillige

Kliniske forsøg med Oral [14C] PF-07799544

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