Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

2. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

32

Fase

  • Fase 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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

Eksperimentell: 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

Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Area Under the Concentration-Time Curve from Time 0 to 12 Hours (AUC0-12) of MK-6916 on Day 16
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AUC0-12 of MK-6916 on Day 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

11. desember 2026

Primær fullføring (Antatt)

6. august 2027

Studiet fullført (Antatt)

8. august 2027

Datoer for studieregistrering

Først innsendt

2. november 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

6. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 6916-013
  • MK-6916-013 (Annen identifikator: MSD)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .