A Phase 1 interventional study of MK-6916 in Healthy and Renal Impairment, sponsored by Merck Sharp & Dohme LLC. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
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.
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's planned enrollment of 32 is below the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The main inclusion criteria include but are not limited to the following:
Moderate and Severe Renal Impairment
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
All participants
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 on Day 1
Blood samples will be collected to determine the AUC0-12 of MK-6916.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
Maximum Plasma Concentration (Cmax) of MK-6916 on Day 1
Blood samples will be collected to determine the Cmax of MK-6916.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 on Day 16
Blood samples will be collected to determine the Cmax of MK-6916.
Time frame: 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
Blood samples will be collected to determine the C12 of MK-6916.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 on Day 16
Blood samples will be collected to determine the C12 of MK-6916.
Time frame: 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
Blood samples will be collected to determine the Tmax of MK-6916.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 on Day 16
Blood samples will be collected to determine the Tmax of MK-6916.
Time frame: 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
Blood samples will be collected to determine the t1/2 of MK-6916.
Time frame: 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
Blood samples will be collected to determine the CL,ss/F of MK-6916.
Time frame: 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
Blood samples will be collected to determine the Vz,ss/F of MK-6916
Time frame: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
AUC0-12 of MK-6916 Metabolite M5 on Day 1
Blood samples will be collected to determine the AUC0-12 of MK-6916 M5.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M9 on Day 1
Blood samples will be collected to determine the AUC0-12 of MK-6916 M9.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M10 on Day 1
Blood samples will be collected to determine the AUC0-12 of MK-6916 M10.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M5 on Day 16
Blood samples will be collected to determine the AUC0-12 of MK-6916 M5.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M9 on Day 16
Blood samples will be collected to determine the AUC0-12 of MK-6916 M9.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M10 on Day 16
Blood samples will be collected to determine the AUC0-12 of MK-6916 M10.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
Cmax of MK-6916 Metabolite M5 on Day 1
Blood samples will be collected to determine the Cmax of MK-6916 M5.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M5 on Day 16
Blood samples will be collected to determine the Cmax of MK-6916 M5.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M9 on Day 1
Blood samples will be collected to determine the Cmax of MK-6916 M9.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M9 on Day 16
Blood samples will be collected to determine the Cmax of MK-6916 M9.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M10 on Day 1
Blood samples will be collected to determine the Cmax of MK-6916 M10.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M10 on Day 16
Blood samples will be collected to determine the Cmax of MK-6916 M10.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
C12 of MK-6916 Metabolite M5 on Day 1
Blood samples will be collected to determine the C12 of MK-6916 M5.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M5 on Day 16
Blood samples will be collected to determine the C12 of MK-6916 M5.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M9 on Day 1
Blood samples will be collected to determine the C12 of MK-6916 M9.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M9 on Day 16
Blood samples will be collected to determine the C12 of MK-6916 M9.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M10 on Day 1
Blood samples will be collected to determine the C12 of MK-6916 M10.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M10 on Day 16
Blood samples will be collected to determine the C12 of MK-6916 M10.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
Tmax of MK-6916 Metabolite M5 on Day 1
Blood samples will be collected to determine the Tmax of MK-6916 M5.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M5 on Day 16
Blood samples will be collected to determine the Tmax of MK-6916 M5.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M9 on Day 1
Blood samples will be collected to determine the Tmax of MK-6916 M9.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M9 on Day 16
Blood samples will be collected to determine the Tmax of MK-6916 M9.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M10 on Day 1
Blood samples will be collected to determine the Tmax of MK-6916 M10.
Time frame: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M10 on Day 16
Blood samples will be collected to determine the Tmax of MK-6916 M10.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
t1/2 of MK-6916 Metabolite M5 on Day 16
Blood samples will be collected to determine the t1/2 of MK-6916 M5.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
t1/2 of MK-6916 Metabolite M9 on Day 16
Blood samples will be collected to determine the t1/2 of MK-6916 M9.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
t1/2 of MK-6916 Metabolite M10 on Day 16
Blood samples will be collected to determine the t1/2 of MK-6916 M10.
Time frame: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
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.
Time frame: Up to approximately 75 days
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.
Time frame: Up to approximately 16 days
No study locations are listed for this record.
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Start is estimated for Dec 2026; primary completion for Aug 2027, 7 months later.
Of 212 industry-sponsored phase 1 interventional studies under Renal Insufficiency, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 7 months is below that.
Counting every sponsor, half of 230 studies reached it within 8 months; a quarter within 5 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: MK-6916