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A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)

2 november 2026 bijgewerkt door: Merck Sharp & Dohme LLC

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

32

Fase

  • Fase 1

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: MK-6916

Oral tablet
Experimenteel: 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.
Geneesmiddel: MK-6916

Oral tablet
Experimenteel: 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.
Geneesmiddel: MK-6916

Oral tablet

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Area Under the Concentration-Time Curve from Time 0 to 12 Hours (AUC0-12) of MK-6916 on Day 16
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
AUC0-12 of MK-6916 on Day 1
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

11 december 2026

Primaire voltooiing (Geschat)

6 augustus 2027

Studie voltooiing (Geschat)

8 augustus 2027

Studieregistratiedata

Eerst ingediend

2 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 november 2026

Eerst geplaatst (Werkelijk)

6 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 6916-013
  • MK-6916-013 (Andere identificatie: MSD)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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