Actively Recruiting
A Two-Part Study to Evaluate How Itraconazole Affects MK-2828 and How MK-2828 Affects Midazolam Levels in Healthy Adults
Led by Merck Sharp & Dohme LLC · Updated on 2026-03-25
28
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the drug MK-2828 behaves in the body when taken with itraconazole, and how MK-2828 affects the levels of another drug called midazolam. This clinical trial focuses on healthy adults and aims to understand how these drugs interact with each other when taken alone or together. The study is sponsored by Merck Sharp & Dohme LLC and is a Phase 1 interventional trial. Participants will take multiple oral doses of itraconazole along with a single oral dose of MK-2828 in the first part of the study. In the second part, participants will receive multiple oral doses of MK-2828 along with a single oral dose of midazolam. Both itraconazole and midazolam are given as syrups, while MK-2828 is given as a capsule. The trial includes two parts to evaluate drug levels and interactions after dosing. During the study, researchers will collect blood samples at various time points up to 288 hours after dosing with itraconazole and up to 24 hours after dosing with midazolam. They will measure how much of each drug is in the blood over time, including peak levels and how quickly the drugs are cleared. Safety will be monitored by recording any side effects and discontinuations. The total participation duration varies depending on the part of the study, with close monitoring of drug levels and participant health.
CONDITIONS
Brief Title
A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is in good health
- Age between 24 and 60 years
You will not qualify if you...
- History of cancer (malignancy)
- History of significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological diseases, including stroke and chronic seizures
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 23 days depending on the part of the study
Participants receive multiple oral doses of Itraconazole with a single oral dose of MK-2828 or multiple oral doses of MK-2828 with a single oral dose of Midazolam.
Multiple visits for drug administration and blood sampling up to approximately 288 hours postdose for Part 1 and up to approximately 24 hours postdose for Part 2
Trial Site Locations
Total: 1 location
1
Fortea CRU Madison ( Site 0001)
Madison, Wisconsin, United States, 53704
Actively Recruiting
Research Team
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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