A Study to Learn if the Study Medicine Called Fluconazole Changes How the Other Body Processes the Study Medicine PF-07248144
4. juni 2026 oppdatert av: Pfizer
A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD, CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF FLUCONAZOLE ON PF-07248144 PHARMACOKINETICS
The purpose of the study is to learn how the study medicine called fluconazole changes how the body processes the other study medicine called PF-07248144. The study will also look at the safety, tolerability, and how the medicine is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with fluconazole.
Fluconazole can change how your body processes some medications so it may change the body's processing of PF-07248144. Multiple blood samples will be collected up to 10 days after each dose of PF-07248144 to determine how much PF-07248144 is in the blood at different times. This will help characterize the pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07248144 alone and when taken with fluconazole.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Bruxelles-capitale, Région de
-
Brussels, Bruxelles-capitale, Région de, Belgia, B-1070
- Pfizer Clinical Research Unit - Brussels
-
-
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
- Male or female of nonchildbearing potential ≥ 18 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- Body mass index (BMI) of 18-32 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).
- Use prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: PF-07248144
PF-07248144 administered by mouth as a single dose in Period 1 and Period 2. Fluconazole administered by mouth once a day for 13 days in Period 2.
|
PF-07248144 administered by mouth as a single dose in Period 1 and Period 2.
Fluconazole administered by mouth once a day for 13 days in Period 2.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07248144 - Period 1
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
|
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
|
|
AUCinf of PF-07248144 - Period 2
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
|
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-07248144 - Period 1
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
|
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
|
|
Cmax of PF-07248144 - Period 2
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
|
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Treatment-Emergent Adverse Events (AE) by Severity
Tidsramme: From Baseline through follow-up, up to 35 days after last dose of study drug in Period 2 (Period 2 is up to 48 days).
|
From Baseline through follow-up, up to 35 days after last dose of study drug in Period 2 (Period 2 is up to 48 days).
|
|
Number of Participants With Clinically Significant Clinical Laboratories Abnormalities
Tidsramme: From Baseline through follow-up, up to 35 days after last dose of study drug in Period 2 (Period 2 is up to 48 days).
|
From Baseline through follow-up, up to 35 days after last dose of study drug in Period 2 (Period 2 is up to 48 days).
|
|
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure or Heart Rate
Tidsramme: From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)
|
From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)
|
|
Number of Participants With Abnormalities in Physical Examination
Tidsramme: From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)
|
From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)
|
|
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Tidsramme: From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)
|
From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
26. august 2025
Primær fullføring (Faktiske)
8. oktober 2025
Studiet fullført (Faktiske)
4. november 2025
Datoer for studieregistrering
Først innsendt
17. juli 2025
Først innsendt som oppfylte QC-kriteriene
4. juni 2026
Først lagt ut (Faktiske)
9. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- C4551010
- 2025-521924-31-00 (Registeridentifikator: CTIS (EU))
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
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
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. .