A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007)

A Two-Part Clinical Study to Evaluate the Effects of Multiple Doses of Itraconazole on the Single-Dose Pharmacokinetics of MK-2828 (Part 1) and Multiple Doses of MK-2828 on the Single-Dose PK of Midazolam (Part 2) in Healthy Participants

The main goals of this study are:

• To learn what happens to one dose of MK-2828 in a healthy person's body over time when it is taken with itraconzole
• To learn what happens to one dose of midazolam in a healthy person's body over time when it is taken with MK-2828

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: MK-2828; Drug: Itraconazole; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Toll Free Number; Phone Number: 1-888-577-8839; Email: Trialsites@merck.com

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Recruiting
      • Fortea CRU Madison ( Site 0001)
      • Contact: Study Coordinator; Phone Number: 608-210-5454

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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:

• History of cancer (malignancy)
• History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Itraconazole; Participants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828.	Drug: MK-2828; Administered orally as capsule; Drug: Itraconazole; Administered orally as syrup
Experimental: Part 2: Midazolam; Participants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam.	Drug: MK-2828; Administered orally as capsule; Drug: Midazolam; Administered orally as syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Predose and at designated timepoints up to approximately 24hrs postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to approximately 9 days

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2026
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): August 12, 2026

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Benzazepines; Benzodiazepines; Triazoles; Piperazines; Midazolam; Itraconazole
• Other Study ID Numbers: 2828-007; MK-2828-007 (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