Recruiting

Effects of Multiple Doses of Itraconazole and MK-2828 on Single-Dose Pharmacokinetics in Healthy Participants

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Study Aim

This phase 1 study aims to evaluate how multiple doses of Itraconazole and MK-2828 affect the body's processing of these drugs in healthy participants, by measuring the maximum concentration and total exposure of these drugs in the bloodstream over time.

What is being tested

MK-2828

+ Itraconazole

+ Midazolam

Drug
Who is being recruted

From 24 to 60 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 6, 2026

Actual date on which the first participant was enrolled.

This study aims to understand how the body processes MK-2828, a new drug, when taken with another drug called itraconazole. It also seeks to learn how the body handles midazolam, another drug, when taken with MK-2828. The study is designed for healthy individuals. By comparing the levels of MK-2828 in the body when taken with and without itraconazole, researchers hope to gain insights into potential drug interactions. They also aim to understand if taking MK-2828 multiple times impacts the body's handling of midazolam after a single dose. Participants in this study will have blood samples collected at various time points. These samples will help determine two key measures: the maximum concentration of MK-2828 and midazolam in the blood, and the total exposure to these drugs over time. This information will provide valuable insights into the body's processing of these drugs when taken in combination.

Official TitleA 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
NCT07435194
Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 24 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
Participant is in good health
2 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828.

Group II

Experimental
Participants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fortrea CRU Madison

Madison, United StatesOpen Fortrea CRU Madison in Google Maps
Recruiting
One Study Center