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Completed

NCT Number: NCT06814132

A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)

The goal of the study is to learn what happens to levels of MK-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time. Researchers will compare what happens to MK-5684 after hemodialysis in people with severe renal impairment and end-stage renal disease versus healthy people.

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Key information

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center ( Site 0002), Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

include, but are not limited to:

All Participants

  • Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to the first dosing
  • Has a body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m^2 at the screening visit

Participants with severe renal impairment (RI) (Group 1):

  • Has severely impaired renal function as determined by estimated glomerular filtration rate (eGFR) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation

Participants with end-stage renal disease (ESRD) (Group 2):

  • Has ESRD maintained on stable outpatient regimen of intermittent high-flux hemodialysis (HD) (at least 3 times per week) for a minimum of 3 hours per dialysis session, using a complication free well-maintained arteriovenous fistula or arteriovenous graft, for at least 3 months prior to first dosing and is expected and planning to continue HD during the study and at least up to the follow-up visit

Healthy Control Participants (Group 3):

  • Has normal renal function

Exclusion criteria

Exclusion criteria

include, but are not limited to:

All Participants:

  • Has a history or presence of any of the following: Adrenal insufficiency; Hepatic impairment; Clinically significant hypotension; cardiac arrhythmia; cardiac conduction abnormalities or recurrent unexplained syncopal events; Second- or third-degree atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker); Clinically significant sick sinus syndrome; Any systemic fungal infection; Hypothyroidism; Chronic infection
  • Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
  • Has a history of cancer (malignancy)
  • Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Participants with Severe RI (Group 1):

  • Has a history or presence of renal artery stenosis
  • Has had a renal transplant
  • Has ESRD requiring HD

Participants with ESRD (Group 2):

  • Has required frequent emergent HD (≥ 3) within a year prior to the first dosing
  • Has a history or presence of renal artery stenosis.
  • Has had a functioning renal transplant within the past 2 years

Treatment and study plan

MK-5684

Drug

Oral tablet

Prednisone

Drug

Oral tablet

Other names: HRT

fludrocortisone acetate

Drug

Oral tablet

Other names: HRT

Primary outcomes

  1. Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) After a Single Dose of MK-5684

    Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose

    Blood samples will be collected to determine the AUC0-inf of MK-5684 in plasma.

  2. Area Under the Concentration Versus Time Curve From 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-5684

    Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose

    Blood samples will be collected to determine the AUC0-last of MK-5684 in plasma.

  3. Area Under the Concentration Versus Time Curve From 0 to 24 Hours After Dosing (AUC0-24) of MK-5684

    Time frame: At protocol specific time points pre-dose and up to 24 hours post-dose

    Blood samples will be collected to determine the AUC0-24 of MK-5684 in plasma.

  4. Maximum Observed Drug Concentration (Cmax) After the Administration of a Given Dose of MK-5684

    Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose

    Blood samples will be collected to determine the Cmax of MK-5684 in plasma.

  5. Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-5684

    Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose

    Blood samples will be collected to determine the Tmax of MK-5684 in plasma.

  6. Apparent Terminal Half-Life (t½) of MK-5684

    Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose

    Blood samples will be collected to determine the t1/2 of MK-5684 in plasma.

  7. Apparent Clearance (CL/F) of MK-5684

    Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose

    Blood samples will be collected to determine the CL/F of MK-5684 in plasma.

  8. Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-5684

    Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose

    Blood samples will be collected to determine the Vz/F of MK-5684 in plasma.

Secondary outcomes

  1. Number of Participants who Experience an Adverse Event (AE)

    Time frame: Up to ~21 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

  2. Number of Participants who Discontinue Study Intervention Due to an AE

    Time frame: Up to ~7 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

  3. Dialysis Clearance (CLD) of MK5684 Based on Plasma

    Time frame: At protocol specific time points pre-dose and up to 4.5 hours post-dose

    Dialysate will be collected to determine the CLD of MK-5684 in plasma.

  4. Concentration of Dialysate (CD) of MK-5684 Samples

    Time frame: At protocol specific time points pre-dose and up to 4.5 hours post-dose

    Dialysate will be collected to determine the CD of MK-5684 in plasma.

  5. Amount of drug (AD) of MK-5684 recovered from each dialysate collection

    Time frame: At protocol specific time points pre-dose and up to 4.5 hours post-dose

    Dialysate will be collected to determine the AD of MK-5684 in plasma.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Severe Renal Impairment and With End-stage Renal Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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