A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)
16 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
44
Faza
- Faza 1
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Part 1: MK-8527
Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.
|
Tablet doustny
|
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Eksperymentalny: 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.
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Tablet doustny
Oral tablet
|
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Eksperymentalny: 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.
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Roztwór doustny
Tablet doustny
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Medical Director, Merck Sharp & Dohme LLC
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
7 lipca 2026
Zakończenie podstawowe (Szacowany)
9 października 2026
Ukończenie studiów (Szacowany)
9 października 2026
Daty rejestracji na studia
Pierwszy przesłany
16 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
16 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
22 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
22 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
16 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 8527-021
- MK-8527-021 (Inny identyfikator: MSD)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .