A Phase 1 interventional study of Midazolam and Rosuvastatin in Healthy, sponsored by Merck Sharp & Dohme LLC. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Basic science
Researchers are looking for new treatments for pain. The goal of this trial is to learn if MK-6916 changes what happens to the midazolam and rosuvastatin in healthy participants' bodies. Researchers will compare the amount of midazolam and rosuvastatin in a participant's body over time when they are given with and without MK-6916.
Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
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Exclusion Criteria:
In Period 1, participants will receive midazolam and rosuvastatin. In Period 2, participants will receive MK-6916, midazolam, and rosuvastatin.
Drug: Midazolam · Drug: Rosuvastatin · Drug: MK-6916
Administered orally on Day 1 of Period 1 and on Days 2 and 14 of Period 2.
Administered orally on Day 1 of Period 1 and Day 14 of Period 2.
Administered orally once every 12 hours on Days 1 through 18 in Period 2.
Period 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam.
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-inf of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam.
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: AUC0-inf of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: AUC0-inf of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: AUC0-inf of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam metabolite (1-hydroxymidazolam).
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-inf of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam metabolite (1-hydroxymidazolam).
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam.
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-last of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam.
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: AUC0-last of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam metabolite (1-hydroxymidazolam).
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-last of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam metabolite (1-hydroxymidazolam).
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Maximum Plasma Concentration (Cmax) of Midazolam
Blood samples will be collected at multiple time points to determine the Cmax of midazolam.
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: Cmax of Midazolam
Blood samples will be collected at multiple time points to determine the Cmax of midazolam.
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Cmax of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the Cmax of midazolam metabolite (1-hydroxymidazolam).
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: Cmax of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the Cmax of midazolam metabolite (1-hydroxymidazolam).
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Time to Maximum Plasma Concentration (Tmax) of Midazolam
Blood samples will be collected at multiple time points to determine the Tmax of midazolam.
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: Tmax of Midazolam
Blood samples will be collected at multiple time points to determine the Tmax of midazolam.
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Tmax of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the Tmax of midazolam metabolite (1-hydroxymidazolam).
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: Tmax of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the Tmax of midazolam metabolite (1-hydroxymidazolam).
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Apparent Terminal Half-life (t1/2) of Midazolam
Blood samples will be collected at multiple time points to determine the t1/2 of midazolam.
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: t1/2 of Midazolam
Blood samples will be collected at multiple time points to determine the t1/2 of midazolam.
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: t1/2 of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the t1/2 of midazolam metabolite (1-hydroxymidazolam).
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: t1/2 of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the t1/2 of midazolam metabolite (1-hydroxymidazolam).
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Apparent Clearance (CL/F) of Midazolam
Blood samples will be collected at multiple time points to determine the CL/F of midazolam.
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: CL/F of Midazolam
Blood samples will be collected at multiple time points to determine the CL/F of midazolam.
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam
Blood samples will be collected at multiple time points to determine the Vz/F of midazolam.
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: Vz/F of Midazolam
Blood samples will be collected at multiple time points to determine the Vz/F of midazolam.
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: AUC0-last of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-last of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: AUC0-last of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-last of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: Cmax of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: Cmax of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: Tmax of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Tmax of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: Tmax of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Tmax of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: t1/2 of Rosuvastatin
Blood samples will be collected at multiple time points to determine the t1/2 of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: t1/2 of Rosuvastatin
Blood samples will be collected at multiple time points to determine the t1/2 of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: CL/F of Rosuvastatin
Blood samples will be collected at multiple time points to determine the CL/F of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: CL/F of Rosuvastatin
Blood samples will be collected at multiple time points to determine the CL/F of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: Vz/F of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Vz/F of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: Vz/F of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Vz/F of rosuvastatin.
Time frame: Predose and at designated timepoints up to approximately Day 19
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported.
Time frame: Up to approximately 2 months
Number of Participants Who Discontinue Study Drug Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 23 days
Period 2 Day 1: Plasma Concentration at 12 Hours (C12) of MK-6916
Blood samples will be collected at multiple time points to determine the C12 of MK-6916.
Time frame: Day 1: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 1: C12 of MK-6916 Metabolite (M5)
Blood samples will be collected at multiple time points to determine the C12 of MK-6916 metabolite (M5).
Time frame: Day 1: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 1: C12 of MK-6916 Metabolite (M9)
Blood samples will be collected at multiple time points to determine the C12 of MK-6916 metabolite (M9).
Time frame: Day 1: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 14: C12 of MK-6916
Blood samples will be collected at multiple time points to determine the C12 of MK-6916.
Time frame: Day 14: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 14: C12 of MK-6916 Metabolite (M5)
Blood samples will be collected at multiple time points to determine the C12 of MK-6916 metabolite (M5).
Time frame: Day 14: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 14: C12 of MK-6916 Metabolite (M9)
Blood samples will be collected at multiple time points to determine the C12 of MK-6916 metabolite (M9).
Time frame: Day 14: predose and at designated timepoints up to approximately 12 hours post dose
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 Nov 2026; primary completion for Feb 2027, 2 months later.
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 drugs tested here: Midazolam · Rosuvastatin · MK-6916