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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Sperimentale: 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 |
|
Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Area Under the Concentration-Time Curve from Time 0 to 12 Hours (AUC0-12) of MK-6916 on Day 16
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
AUC0-12 of MK-6916 on Day 1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 6916-013
- MK-6916-013 (Altro identificatore: MSD)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
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