Studie MK-8507 a Islatraviru (MK-8591) u zdravých dospělých účastníků (MK-8507-016)
Otevřená studie k posouzení dvoucestné interakce mezi vícenásobnými týdenními dávkami MK-8507 a jednotlivými dávkami Islatraviru (MK-8591) u zdravých dospělých účastníků
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.
Přehled studie
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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Nebraska
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Lincoln, Nebraska, Spojené státy, 68502
- Celerion (Site 0001)
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
Časové okno: At designated timepoints (up to approximately 43 days)
|
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
Časové okno: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite. |
At designated timepoints (up to approximately 168 hours)
|
|
Maximum Concentration (Cmax) of Islatravir Metabolite
Časové okno: At designated timepoints (up to approximately 43 days)
|
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
Časové okno: At designated timepoints (up to approximately 168 hours)
|
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
Časové okno: At designated timepoints (up to approximately 43 days)
|
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
Časové okno: At designated timepoints (up to approximately 43 days)
|
Blood samples will be collected to determine the t1/2 of Islatravir metabolite. |
At designated timepoints (up to approximately 43 days)
|
|
AUC0-Inf of Islatravir
Časové okno: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the AUC0-Inf of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
AUC0-168hrs of Islatravir
Časové okno: At designated timepoints (up to approximately 7 days)
|
Blood samples will be collected to determine the AUC0-168hrs of Islatravir. |
At designated timepoints (up to approximately 7 days)
|
|
Cmax of Islatravir
Časové okno: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine Cmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
C168 of Islatravir
Časové okno: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of Islatravir. |
At designated timepoints (up to approximately 168 hours)
|
|
Tmax of Islatravir
Časové okno: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the Tmax of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
t1/2 of Islatravir
Časové okno: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the t1/2 of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
Apparent clearance (CL/F) of Islatravir
Časové okno: At designated timepoints (up to approximately 22 days)
|
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
Časové okno: At designated timepoints (up to approximately 22 days)
|
Blood samples will be collected to determine the Vd/F of Islatravir. |
At designated timepoints (up to approximately 22 days)
|
|
AUC0-168hrs of MK-8507
Časové okno: At designated timepoints (up to approximately 7 days)
|
Blood samples will be collected to determine the AUC0-168hrs of MK-8507. |
At designated timepoints (up to approximately 7 days)
|
|
Cmax of MK-8507
Časové okno: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine Cmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
C168 of MK-8507
Časové okno: At designated timepoints (up to approximately 168 hours)
|
Blood samples will be collected to determine the C168 of MK-8507. |
At designated timepoints (up to approximately 168 hours)
|
|
Tmax of MK-8507
Časové okno: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the Tmax of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
t1/2 of MK-8507
Časové okno: 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)
|
|
CL/F of MK-8507
Časové okno: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the CL/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
|
Vd/F of MK-8507
Časové okno: At designated timepoints (up to approximately 15 days)
|
Blood samples will be collected to determine the Vd/F of MK-8507. |
At designated timepoints (up to approximately 15 days)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants Who Experience an Adverse Event (AE)
Časové okno: Up to approximately 5 months
|
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
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Časové okno: Up to approximately 5 months
|
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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Medical Director, Merck Sharp & Dohme LLC
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 8507-016
- MK-8507-016 (Jiný identifikátor: MSD)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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