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A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults

11. juni 2026 oppdatert av: Pfizer

A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF ONE IMMEDIATE RELEASE AND TWO MODIFIED-RELEASE FORMULATIONS OF PF-08049820 ADMINISTERED ORALLY UNDER FASTED AND FED CONDITIONS (PART A), AND A FIXED SEQUENCE STUDY TO ASSESS THE EFFECT OF RABEPRAZOLE ON THE PHARMACOKINETICS OF PF-08049820 (PART B), IN HEALTHY ADULTS

The purpose of this study is to learn how different forms of the study medicine called PF-08049820 are absorbed and eliminated in healthy adults. The study will assess whether the study medicine is absorbed differently when taken with or without food. It will also assess absorption when the study medicine is taken with another medicine called rabeprazole. Rabeprazole is an FDA approved medicine that reduces stomach acid.

The study has two parts. In Part A, participants will take three forms of study medicine, one after the other. They will take each form either with or without food for a total of five doses. Each dose will be separated by a few days. Participants will stay in the clinic for about two weeks. They will receive a telephone follow-up call about a month after the last dose.

In Part B, participants will take three forms of study medicine. They will take each one with or without food, and with or without another medicine called rabeprazole. This means they will take a total of six doses of study medicine. Each dose will be separated by a few days. Participants will stay at the clinic for about three weeks, and about a month after their last dose. They will get a follow-up phone call. Part B may or may not be conducted depending on the results from Part A.

The study is seeking participants who:

  1. Are males or females,
  2. Are at least 18 years of age,
  3. Have a body mass index (BMI) 16 to 32 kilograms per meter squared (kg/m2). Have a total body weight of more than 50 kilograms (kg) (110 pounds).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

24

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06511
        • Rekruttering
        • Pfizer Clinical Research Unit - New Haven

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Healthy males and females.
  2. At least 18 years of age
  3. Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.).

Exclusion Criteria:

  1. Evidence or history of clinically significant medical conditions.
  2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B or hepatitis C.
  3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Sequence 1 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Legemiddel: PF-08049820
Administrert muntlig
Eksperimentell: Sequence 2 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Legemiddel: PF-08049820
Administrert muntlig
Eksperimentell: Sequence 3 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Legemiddel: PF-08049820
Administrert muntlig
Eksperimentell: Sequence 4 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Legemiddel: PF-08049820
Administrert muntlig
Eksperimentell: Sequence 5 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Legemiddel: PF-08049820
Administrert muntlig
Eksperimentell: Sequence 6 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions.
Legemiddel: PF-08049820
Administrert muntlig
Eksperimentell: Sequence 7 (Optional Part B)
3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions.
Legemiddel: PF-08049820
Administrert muntlig
Legemiddel: Rabeprazole
Administered orally

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Tidsramme: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B

Part A: Evaluate the relative bioavailability of different formulations of PF-08049820.

Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Tidsramme: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B

Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820.

Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Maximum observed plasma concentration (Cmax)
Tidsramme: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B

Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820.

Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
Part A and optional Part B
Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
Part A and optional Part B
Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Tidsramme: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Part A and optional Part B
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Tidsramme: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Part A and optional Part B
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Tidsramme: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Part A and optional Part B
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Tidsramme: Baseline up to Day 16 for Part A
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.
Baseline up to Day 16 for Part A
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Tidsramme: Baseline up to Day 16 for Part A
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.
Baseline up to Day 16 for Part A
Maximum observed plasma concentration (Cmax)
Tidsramme: Baseline up to Day 16 for Part A
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.
Baseline up to Day 16 for Part A

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. mai 2026

Primær fullføring (Antatt)

3. september 2026

Studiet fullført (Antatt)

25. september 2026

Datoer for studieregistrering

Først innsendt

12. mai 2026

Først innsendt som oppfylte QC-kriteriene

12. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C6231008

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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