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

16. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

44

Fáze

  • Fáze 1

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Part 1: MK-8527
Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.
Lék: MK-8527
Orální tablet
Experimentální: 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.
Lék: MK-8527
Orální tablet
Lék: Probenecid
Oral tablet
Experimentální: 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.
Lék: Itrakonazol
Orální roztok
Lék: MK-8527
Orální tablet

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Merck Sharp & Dohme LLC

Vyšetřovatelé

  • Ředitel studie: Medical Director, Merck Sharp & Dohme LLC

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

7. července 2026

Primární dokončení (Odhadovaný)

9. října 2026

Dokončení studie (Odhadovaný)

9. října 2026

Termíny zápisu do studia

První předloženo

16. června 2026

První předloženo, které splnilo kritéria kontroly kvality

16. června 2026

První zveřejněno (Aktuální)

22. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 8527-021
  • MK-8527-021 (Jiný identifikátor: MSD)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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