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HealthyPhase 1NCT07922174

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

A Phase 1 study testing MK-6916 in people with Healthy and Renal Impairment, run by Merck Sharp & Dohme LLC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Renal Impairment
What is being tested?
MK-6916
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
11 Dec 2026to 8 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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.

Being tested
MK-6916
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-6916Drug

    Oral tablet

Study groups in NCT07922174
Study groupRoleWhat they receive
Panel A: Severe Renal ImpairmentExperimentalParticipants 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.
Receives: Drug: MK-6916
Panel B: Moderate Renal ImpairmentExperimentalParticipants 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.
Receives: Drug: MK-6916
Panel C: HealthyExperimentalHealthy participants will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions.
Receives: Drug: MK-6916

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Concentration-Time Curve from Time 0 to 12 Hours (AUC0-12) of MK-6916 on Day 16

    Blood samples will be collected to determine the AUC0-12 of MK-6916.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Secondary outcomes (39)
  1. AUC0-12 of MK-6916 on Day 1

    Blood samples will be collected to determine the AUC0-12 of MK-6916.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

  2. Maximum Plasma Concentration (Cmax) of MK-6916 on Day 1

    Blood samples will be collected to determine the Cmax of MK-6916.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

  3. Cmax of MK-6916 on Day 16

    Blood samples will be collected to determine the Cmax of MK-6916.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  4. Plasma Concentration at 12 Hours (C12) of MK-6916 on Day 1

    Blood samples will be collected to determine the C12 of MK-6916.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

  5. C12 of MK-6916 on Day 16

    Blood samples will be collected to determine the C12 of MK-6916.

    Measured: Day 16: Predose and at designated timepoints(up to approximately 12 hours postdose)

  6. Time to Maximum Plasma Concentration (Tmax) of MK-6916 on Day 1

    Blood samples will be collected to determine the Tmax of MK-6916.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

  7. Tmax of MK-6916 on Day 16

    Blood samples will be collected to determine the Tmax of MK-6916.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  8. Apparent Terminal Half-life (t1/2) of MK-6916 on Day 16

    Blood samples will be collected to determine the t1/2 of MK-6916.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  9. Clearance at Steady State (CL,ss/F) of MK-6916 on Day 16

    Blood samples will be collected to determine the CL,ss/F of MK-6916.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  10. Apparent Volume of Distribution at Steady State (Vz,ss/F) of MK-6916 on Day 16

    Blood samples will be collected to determine the Vz,ss/F of MK-6916

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  11. AUC0-12 of MK-6916 Metabolite M5 on Day 1

    Blood samples will be collected to determine the AUC0-12 of MK-6916 M5.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

  12. AUC0-12 of MK-6916 Metabolite M9 on Day 1

    Blood samples will be collected to determine the AUC0-12 of MK-6916 M9.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

  13. AUC0-12 of MK-6916 Metabolite M10 on Day 1

    Blood samples will be collected to determine the AUC0-12 of MK-6916 M10.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

  14. AUC0-12 of MK-6916 Metabolite M5 on Day 16

    Blood samples will be collected to determine the AUC0-12 of MK-6916 M5.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

  15. AUC0-12 of MK-6916 Metabolite M9 on Day 16

    Blood samples will be collected to determine the AUC0-12 of MK-6916 M9.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

  16. AUC0-12 of MK-6916 Metabolite M10 on Day 16

    Blood samples will be collected to determine the AUC0-12 of MK-6916 M10.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

  17. Cmax of MK-6916 Metabolite M5 on Day 1

    Blood samples will be collected to determine the Cmax of MK-6916 M5.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

  18. Cmax of MK-6916 Metabolite M5 on Day 16

    Blood samples will be collected to determine the Cmax of MK-6916 M5.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  19. Cmax of MK-6916 Metabolite M9 on Day 1

    Blood samples will be collected to determine the Cmax of MK-6916 M9.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

  20. Cmax of MK-6916 Metabolite M9 on Day 16

    Blood samples will be collected to determine the Cmax of MK-6916 M9.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  21. Cmax of MK-6916 Metabolite M10 on Day 1

    Blood samples will be collected to determine the Cmax of MK-6916 M10.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

  22. Cmax of MK-6916 Metabolite M10 on Day 16

    Blood samples will be collected to determine the Cmax of MK-6916 M10.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  23. C12 of MK-6916 Metabolite M5 on Day 1

    Blood samples will be collected to determine the C12 of MK-6916 M5.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

  24. C12 of MK-6916 Metabolite M5 on Day 16

    Blood samples will be collected to determine the C12 of MK-6916 M5.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

  25. C12 of MK-6916 Metabolite M9 on Day 1

    Blood samples will be collected to determine the C12 of MK-6916 M9.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

  26. C12 of MK-6916 Metabolite M9 on Day 16

    Blood samples will be collected to determine the C12 of MK-6916 M9.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

  27. C12 of MK-6916 Metabolite M10 on Day 1

    Blood samples will be collected to determine the C12 of MK-6916 M10.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

  28. C12 of MK-6916 Metabolite M10 on Day 16

    Blood samples will be collected to determine the C12 of MK-6916 M10.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

  29. Tmax of MK-6916 Metabolite M5 on Day 1

    Blood samples will be collected to determine the Tmax of MK-6916 M5.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

  30. Tmax of MK-6916 Metabolite M5 on Day 16

    Blood samples will be collected to determine the Tmax of MK-6916 M5.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  31. Tmax of MK-6916 Metabolite M9 on Day 1

    Blood samples will be collected to determine the Tmax of MK-6916 M9.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

  32. Tmax of MK-6916 Metabolite M9 on Day 16

    Blood samples will be collected to determine the Tmax of MK-6916 M9.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  33. Tmax of MK-6916 Metabolite M10 on Day 1

    Blood samples will be collected to determine the Tmax of MK-6916 M10.

    Measured: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

  34. Tmax of MK-6916 Metabolite M10 on Day 16

    Blood samples will be collected to determine the Tmax of MK-6916 M10.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  35. t1/2 of MK-6916 Metabolite M5 on Day 16

    Blood samples will be collected to determine the t1/2 of MK-6916 M5.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  36. t1/2 of MK-6916 Metabolite M9 on Day 16

    Blood samples will be collected to determine the t1/2 of MK-6916 M9.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  37. t1/2 of MK-6916 Metabolite M10 on Day 16

    Blood samples will be collected to determine the t1/2 of MK-6916 M10.

    Measured: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

  38. Number of Participants Who Experience an Adverse Event (AE)

    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.

    Measured: Up to approximately 75 days

  39. Number of Participants Who Discontinue Study Treatment Due to an AE

    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.

    Measured: Up to approximately 16 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start11 Dec 2026 (estimated)
  3. Primary completion6 Aug 2027 (estimated)
  4. Study completion8 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07922174
Sponsor's protocol ID
6916-013
Other IDs
MK-6916-013
Status last verified
Oct 2026
First submitted
2 Nov 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-6916 in people with Healthy and Renal Impairment, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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