A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
An Open-Label, Multiple-dose, Parallel Group Study to Evaluate the Pharmacokinetics of MK-6916 in Participants With Severe Renal Impairment and Moderate Renal Impairment
The purpose of this study is to learn what happens to MK-6916 in a person's body when given to participants with moderate or severe kidney impairment compared to healthy participants.
Přehled studie
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Moderate and Severe Renal Impairment
- Except for severe or moderate renal impairment, is sufficiently healthy for study participation
- Has stable renal function Healthy
- Matches mean age to participants with moderate and severe renal impairment
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
All participants
- Has history of cancer (malignancy)
- Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)
- Has had major surgery and/or donated or lost 1 unit of blood within 4 weeks prior to pretrial Participants with Renal Impairment
- Has a history of renal artery stenosis, failed renal transplant or has had a nephrectomy, or end stage renal disease requiring dialysis
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Panel A: Severe Renal Impairment
Participants with severe renal impairment will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions. |
Oral tablet |
|
Experimentální: Panel B: Moderate Renal Impairment
Participants with moderate renal impairment will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions. |
Oral tablet |
|
Experimentální: Panel C: Healthy
Healthy participants will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions. |
Oral tablet |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Area Under the Concentration-Time Curve from Time 0 to 12 Hours (AUC0-12) of MK-6916 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
AUC0-12 of MK-6916 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
Maximum Plasma Concentration (Cmax) of MK-6916 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Plasma Concentration at 12 Hours (C12) of MK-6916 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 on Day 16
Časové okno: Day 16: Predose and at designated timepoints(up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916. |
Day 16: Predose and at designated timepoints(up to approximately 12 hours postdose)
|
|
Time to Maximum Plasma Concentration (Tmax) of MK-6916 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Apparent Terminal Half-life (t1/2) of MK-6916 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the t1/2 of MK-6916. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Clearance at Steady State (CL,ss/F) of MK-6916 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the CL,ss/F of MK-6916. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Apparent Volume of Distribution at Steady State (Vz,ss/F) of MK-6916 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Vz,ss/F of MK-6916 |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M5 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M5. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M9 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M9. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M10 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M10. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M5 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M5. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M9 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M9. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
AUC0-12 of MK-6916 Metabolite M10 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the AUC0-12 of MK-6916 M10. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
Cmax of MK-6916 Metabolite M5 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M5. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 Metabolite M5 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M5. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 Metabolite M9 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M9. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 Metabolite M9 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M9. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 Metabolite M10 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M10. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Cmax of MK-6916 Metabolite M10 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Cmax of MK-6916 M10. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
C12 of MK-6916 Metabolite M5 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M5. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 Metabolite M5 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M5. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 Metabolite M9 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M9. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 Metabolite M9 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M9. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 Metabolite M10 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M10. |
Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
C12 of MK-6916 Metabolite M10 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
Blood samples will be collected to determine the C12 of MK-6916 M10. |
Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
|
|
Tmax of MK-6916 Metabolite M5 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M5. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 Metabolite M5 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M5. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 Metabolite M9 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M9. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 Metabolite M9 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M9. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 Metabolite M10 on Day 1
Časové okno: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M10. |
Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Tmax of MK-6916 Metabolite M10 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the Tmax of MK-6916 M10. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
t1/2 of MK-6916 Metabolite M5 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the t1/2 of MK-6916 M5. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
t1/2 of MK-6916 Metabolite M9 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the t1/2 of MK-6916 M9. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
t1/2 of MK-6916 Metabolite M10 on Day 16
Časové okno: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
Blood samples will be collected to determine the t1/2 of MK-6916 M10. |
Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
|
|
Number of Participants Who Experience an Adverse Event (AE)
Časové okno: Up to approximately 75 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 an AE will be reported. |
Up to approximately 75 days
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Časové okno: Up to approximately 16 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 16 days
|
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 (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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
- 6916-013
- MK-6916-013 (Jiný identifikátor: MSD)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
https://trialstransparency.msdclinicaltrials.com/pdf/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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