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A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)

16. juni 2026 opdateret af: Merck Sharp & Dohme LLC

An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants

Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.

The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

44

Fase

  • Fase 1

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:

  • Be in good health
  • Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive

Exclusion Criteria:

  • Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m^2
  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
  • Has a history of cancer (malignancy)
  • Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)

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: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part 1: MK-8527
Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.
Medicin: MK-8527
Oral tablet
Eksperimentel: Part 2: MK-8527 + Probenecid
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid.
Medicin: MK-8527
Oral tablet
Medicin: Probenecid
Oral tablet
Eksperimentel: Part 3: MK-8527 + Itraconazole
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole.
Medicin: Itraconazol
Oral opløsning
Medicin: MK-8527
Oral tablet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Tidsramme: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.
Up to approximately 43 days
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Tidsramme: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 43 days
Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 2: Tmax of MK-8527 in Plasma with and without Probenecid
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 2: Urine Concentration at 72 Hours of MK-8527
Tidsramme: At designated timepoints (up to 72 hours postdose)
Urine samples will be collected to estimate the urine concentration of MK-8527.
At designated timepoints (up to 72 hours postdose)
Part 2: Renal Clearance of MK-8527
Tidsramme: At designated timepoints (up to 72 hours postdose)
Urine samples will be collected to estimate the renal clearance of MK-8527.
At designated timepoints (up to 72 hours postdose)
Part 2: Number of Participants Who Experience an AE
Tidsramme: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.
Up to approximately 43 days
Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
Tidsramme: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 43 days
Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole
Tidsramme: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected to estimate the apparent t1/2 of MK-8527 in plasma.
Predose and at designated timepoints (up to 336 hours postdose)
Part 3: Urine Concentration at 72 Hours of MK-8527
Tidsramme: At designated timepoints (up to 72 hours postdose)
Urine samples will be collected to estimate the urine concentration of MK-8527.
At designated timepoints (up to 72 hours postdose)
Part 3: Renal Clearance of MK-8527
Tidsramme: At designated timepoints (up to 72 hours postdose)
Urine samples will be collected to estimate the renal clearance of MK-8527.
At designated timepoints (up to 72 hours postdose)
Part 3: Number of Participants Who Experience an AE
Tidsramme: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.
Up to approximately 43 days
Part 3: Number of Participants Who Discontinue Study Treatment Due to an AE
Tidsramme: Up to approximately 43 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 43 days

Samarbejdspartnere og efterforskere

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

Sponsor

Merck Sharp & Dohme LLC

Efterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

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)

7. juli 2026

Primær færdiggørelse (Anslået)

9. oktober 2026

Studieafslutning (Anslået)

9. oktober 2026

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 8527-021
  • MK-8527-021 (Anden identifikator: MSD)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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 Itraconazol

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner