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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 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Not Provided.

Tipo di studio

Interventistico

Iscrizione (Stimato)

9

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: Oral [14C] PF-07799544
A single oral dose of [14C] PF-07799544 will be administered as an extemporaneous suspension in Period 1.
Droga: Oral Unlabeled PF-07799544
A single oral dose of unlabeled PF-07799544 will be administered as extemporaneous solution in Period 2.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total recovery (%) of radioactivity in urine, feces and vomitus (if any), expressed as a percent of total oral radioactive dose administered.
Lasso di tempo: 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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The ratio of dose-normalized AUCinf (if data permit, otherwise AUClast) of oral PF-07799544 to IV [14C]PF-07799544.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Investigatori

  • Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 maggio 2026

Completamento primario (Stimato)

12 settembre 2026

Completamento dello studio (Stimato)

12 settembre 2026

Date di iscrizione allo studio

Primo inviato

5 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

11 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • C4901004

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Volontari maschi sani

Prove cliniche su Oral [14C] PF-07799544

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Malattie rare

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