Badanie MK-8507 i Islatraviru (MK-8591) u zdrowych dorosłych uczestników (MK-8507-016)
Badanie otwarte mające na celu ocenę dwukierunkowej interakcji pomiędzy wieloma cotygodniowymi dawkami MK-8507 a pojedynczymi dawkami islatrawiru (MK-8591) u zdrowych dorosłych uczestników
The main goals of this study are to learn what happens to Islatravir or MK-8507 in a person's body over time. Researchers will compare Islatravir given alone to Islatravir given with MK-8507. Researchers will also compare MK-8507 given alone to MK-8507 given with Islatravir.
Przegląd badań
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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Nebraska
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Lincoln, Nebraska, Stany Zjednoczone, 68502
- Celerion (Site 0001)
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
- 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 cancer with protocol specified exceptions
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Islatravir+MK-8507
Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29. |
Oral administration Oral administration
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
Ramy czasowe: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite
Ramy czasowe: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
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Maximum Concentration (Cmax) of Islatravir Metabolite
Ramy czasowe: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine Cmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite
Ramy czasowe: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the C168 of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
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Time to Maximum Concentration (Tmax) of Islatravir Metabolite
Ramy czasowe: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine the Tmax of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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Apparent Terminal Half-life (t1/2) of Islatravir Metabolite
Ramy czasowe: At designated timepoints (up to approximately 43 days)
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Blood samples will be collected to determine the t1/2 of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
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AUC0-Inf of Islatravir
Ramy czasowe: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the AUC0-Inf of Islatravir. |
At designated timepoints (up to approximately 22 days)
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AUC0-168hrs of Islatravir
Ramy czasowe: At designated timepoints (up to approximately 7 days)
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Blood samples will be collected to determine the AUC0-168hrs of Islatravir. |
At designated timepoints (up to approximately 7 days)
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Cmax of Islatravir
Ramy czasowe: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine Cmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
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C168 of Islatravir
Ramy czasowe: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the C168 of Islatravir. |
At designated timepoints (up to approximately 168 hours)
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Tmax of Islatravir
Ramy czasowe: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the Tmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
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t1/2 of Islatravir
Ramy czasowe: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the t1/2 of Islatravir. |
At designated timepoints (up to approximately 22 days)
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Apparent clearance (CL/F) of Islatravir
Ramy czasowe: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the CL/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
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Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir
Ramy czasowe: At designated timepoints (up to approximately 22 days)
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Blood samples will be collected to determine the Vd/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
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AUC0-168hrs of MK-8507
Ramy czasowe: At designated timepoints (up to approximately 7 days)
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Blood samples will be collected to determine the AUC0-168hrs of MK-8507. |
At designated timepoints (up to approximately 7 days)
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Cmax of MK-8507
Ramy czasowe: At designated timepoints (up to approximately 15 days)
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Blood samples will be collected to determine Cmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
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C168 of MK-8507
Ramy czasowe: At designated timepoints (up to approximately 168 hours)
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Blood samples will be collected to determine the C168 of MK-8507. |
At designated timepoints (up to approximately 168 hours)
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Tmax of MK-8507
Ramy czasowe: At designated timepoints (up to approximately 15 days)
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Blood samples will be collected to determine the Tmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
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t1/2 of MK-8507
Ramy czasowe: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the t1/2 of MK-8507. |
At designated timepoints (up to approximately 15 days)
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CL/F of MK-8507
Ramy czasowe: At designated timepoints (up to approximately 15 days)
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Blood samples will be collected to determine the CL/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
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Vd/F of MK-8507
Ramy czasowe: At designated timepoints (up to approximately 15 days)
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Blood samples will be collected to determine the Vd/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants Who Experience an Adverse Event (AE)
Ramy czasowe: Up to approximately 5 months
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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 an AE will be reported. |
Up to approximately 5 months
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Number of Participants Who Discontinue Study Treatment Due to an AE
Ramy czasowe: Up to approximately 5 months
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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 5 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Medical Director, Merck Sharp & Dohme LLC
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 8507-016
- MK-8507-016 (Inny identyfikator: MSD)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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