A Phase 1 interventional study of MK-2828 and Itraconazole in Healthy, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in United States. Open to participants aged 24 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Basic science
The main goals of this study are:
Researchers want to learn if the levels of MK-2828 in the body are about the same when MK-2828 is taken with itraconazole as when it is taken alone. They also want to know if taking MK-2828 more than once affects how much midazolam is in the body after a single dose.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The main inclusion criteria include but are not limited to the following:
- Participant is in good health
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Participants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828.
Drug: MK-2828 · Drug: Itraconazole
Participants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam.
Drug: MK-2828 · Drug: Midazolam
Administered orally as capsule
Administered orally as syrup
Administered orally as syrup
Part 1 (Itraconazole): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-2828
Blood samples will be collected at multiple time points to determine the AUC0-inf of MK-2828.
Time frame: Predose and at designated timepoints up to approximately 288 hours (hrs) postdose
Part 1 (Itraconazole): Maximum Plasma Concentration (Cmax) of MK-2828
Blood samples will be collected at multiple time points to determine the Cmax of MK-2828.
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 2 (Midazolam): 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 24hrs postdose
Part 2 (Midazolam): 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 24hrs postdose
Part 1 (Itraconazole): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-2828
Blood samples will be collected at multiple time points to determine the AUC0-last of MK-2828.
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of MK-2828
Blood samples will be collected at multiple time points to determine the AUC0-24 of MK-2828.
Time frame: Predose and at designated timepoints up to approximately 24 hrs postdose
Part 1 (Itraconazole): Time to Maximum Plasma Concentration (Tmax) of MK-2828
Blood samples will be collected at multiple time points to determine the Tmax of MK-2828.
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Apparent Terminal Half-life (t1/2) of MK-2828
Blood samples will be collected at multiple time points to determine the t1/2 of MK-2828.
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Apparent Clearance (CL/F) of MK-2828
Blood samples will be collected at multiple time points to determine the CL/F of MK-2828.
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Plasma Concentration at 24 Hours (C24) of MK-2828
Blood samples will be collected at multiple time points to determine the C24 of MK-2828.
Time frame: 24 hours postdose
Part 1 (Itraconazole): Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-2828
Blood samples will be collected at multiple time points to determine the Vz/F of MK-2828.
Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose
Part 1 (Itraconazole): Number of Participants Experiencing an Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
Time frame: Up to approximately 28 days
Part 1 (Itraconazole): Number of Participants Who Discontinue Study Treatment 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported.
Time frame: Up to approximately 23 days
Part 2 (Midazolam): 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 24hrs postdose
Part 2 (Midazolam): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-24 of Midazolam.
Time frame: Predose and at designated timepoints up to approximately 24hrs postdose
Part 2 (Midazolam): 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 24hrs postdose
Part 2 (Midazolam): 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 24hrs postdose
Part 2 (Midazolam): 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 24hrs postdose
Part 2 (Midazolam): Plasma Concentration at 24 Hours (C24) of Midazolam
Blood samples will be collected at multiple time points to determine the C24 of Midazolam.
Time frame: 24 hours postdose
Part 2 (Midazolam): 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 24hrs postdose
Part 2 (Midazolam): Number of Participants Experiencing an adverse event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
Time frame: Up to approximately 23 days
Part 2 (Midazolam): Number of Participants Who Discontinue Study Treatment 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported.
Time frame: Up to approximately 9 days
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC