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

November 2, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: MK-6916

Oral tablet
Experimental: 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.
Drug: MK-6916

Oral tablet
Experimental: 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.
Drug: MK-6916

Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve from Time 0 to 12 Hours (AUC0-12) of MK-6916 on Day 16
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-12 of MK-6916 on Day 1
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 11, 2026

Primary Completion (Estimated)

August 6, 2027

Study Completion (Estimated)

August 8, 2027

Study Registration Dates

First Submitted

November 2, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6916-013
  • MK-6916-013 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe