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NCT Number: NCT07435194

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

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.

Recruiting

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Key information

Conditions

Healthy

Age range

24 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortea CRU Madison ( Site 0001)

Madison, Wisconsin, 53704, United States

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

608-210-5454

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-2828

Drug

Administered orally as capsule

Itraconazole

Drug

Administered orally as syrup

midazolam

Drug

Administered orally as syrup

Primary outcomes

  1. Part 1 (Itraconazole): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-2828

    Time frame: Predose and at designated timepoints up to approximately 288 hours (hrs) postdose

    Blood samples will be collected at multiple time points to determine the AUC0-inf of MK-2828.

  2. Part 1 (Itraconazole): Maximum Plasma Concentration (Cmax) of MK-2828

    Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose

    Blood samples will be collected at multiple time points to determine the Cmax of MK-2828.

  3. Part 2 (Midazolam): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam

    Time frame: Predose and at designated timepoints up to approximately 24hrs postdose

    Blood samples will be collected at multiple time points to determine the AUC0-inf of Midazolam.

  4. Part 2 (Midazolam): Maximum Plasma Concentration (Cmax) of Midazolam

    Time frame: Predose and at designated timepoints up to approximately 24hrs postdose

    Blood samples will be collected at multiple time points to determine the Cmax of Midazolam.

Secondary outcomes

  1. Part 1 (Itraconazole): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-2828

    Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose

    Blood samples will be collected at multiple time points to determine the AUC0-last of MK-2828.

  2. Part 1 (Itraconazole): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of MK-2828

    Time frame: Predose and at designated timepoints up to approximately 24 hrs postdose

    Blood samples will be collected at multiple time points to determine the AUC0-24 of MK-2828.

  3. Part 1 (Itraconazole): Time to Maximum Plasma Concentration (Tmax) of MK-2828

    Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose

    Blood samples will be collected at multiple time points to determine the Tmax of MK-2828.

  4. Part 1 (Itraconazole): Apparent Terminal Half-life (t1/2) of MK-2828

    Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose

    Blood samples will be collected at multiple time points to determine the t1/2 of MK-2828.

  5. Part 1 (Itraconazole): Apparent Clearance (CL/F) of MK-2828

    Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose

    Blood samples will be collected at multiple time points to determine the CL/F of MK-2828.

  6. Part 1 (Itraconazole): Plasma Concentration at 24 Hours (C24) of MK-2828

    Time frame: 24 hours postdose

    Blood samples will be collected at multiple time points to determine the C24 of MK-2828.

  7. Part 1 (Itraconazole): Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-2828

    Time frame: Predose and at designated timepoints up to approximately 288 hrs postdose

    Blood samples will be collected at multiple time points to determine the Vz/F of MK-2828.

  8. Part 1 (Itraconazole): Number of Participants Experiencing an Adverse Event (AE)

    Time frame: Up to approximately 28 days

    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.

  9. Part 1 (Itraconazole): Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 23 days

    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.

  10. Part 2 (Midazolam): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam

    Time frame: Predose and at designated timepoints up to approximately 24hrs postdose

    Blood samples will be collected at multiple time points to determine the AUC0-last of Midazolam.

  11. Part 2 (Midazolam): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Midazolam

    Time frame: Predose and at designated timepoints up to approximately 24hrs postdose

    Blood samples will be collected at multiple time points to determine the AUC0-24 of Midazolam.

  12. Part 2 (Midazolam): Time to Maximum Plasma Concentration (Tmax) of Midazolam

    Time frame: Predose and at designated timepoints up to approximately 24hrs postdose

    Blood samples will be collected at multiple time points to determine the Tmax of Midazolam.

  13. Part 2 (Midazolam): Apparent Terminal Half-life (t1/2) of Midazolam

    Time frame: Predose and at designated timepoints up to approximately 24hrs postdose

    Blood samples will be collected at multiple time points to determine the t1/2 of Midazolam.

  14. Part 2 (Midazolam): Apparent Clearance (CL/F) of Midazolam

    Time frame: Predose and at designated timepoints up to approximately 24hrs postdose

    Blood samples will be collected at multiple time points to determine the CL/F of Midazolam.

  15. Part 2 (Midazolam): Plasma Concentration at 24 Hours (C24) of Midazolam

    Time frame: 24 hours postdose

    Blood samples will be collected at multiple time points to determine the C24 of Midazolam.

  16. Part 2 (Midazolam): Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam

    Time frame: Predose and at designated timepoints up to approximately 24hrs postdose

    Blood samples will be collected at multiple time points to determine the Vz/F of Midazolam.

  17. Part 2 (Midazolam): Number of Participants Experiencing an adverse event (AE)

    Time frame: Up to approximately 23 days

    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.

  18. Part 2 (Midazolam): Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 9 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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