How itraconazole affects MK-2828 levels and how MK-2828 affects midazolam levels in healthy people.
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
This study tests whether itraconazole changes how much MK-2828 stays in the body and whether taking MK-2828 changes midazolam levels in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 24 Years to 60 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT07435194 on ClinicalTrials.gov |
What this trial studies
This Phase 1 pharmacokinetic interaction study enrolls healthy adults to measure blood levels of MK-2828 and midazolam under different dosing conditions. Participants will receive single doses of MK-2828 alone and with itraconazole to see whether itraconazole alters MK-2828 exposure, and will receive repeated MK-2828 dosing followed by a single dose of midazolam to see if MK-2828 alters midazolam exposure. Serial blood samples will be collected over time to measure drug concentrations and calculate standard PK metrics such as AUC and Cmax. Safety and tolerability will be monitored throughout the study.
Who should consider this trial
Good fit: Healthy adults with no major medical conditions who pass screening and are not taking interacting medications are suitable candidates.
Not a fit: People with active cancer, significant organ disease, or other excluded medical conditions (and those who need therapeutic treatment) are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, results could help clinicians avoid dangerous drug interactions and set safe dosing when MK-2828 is used with other medicines.
How similar studies have performed: Similar phase 1 drug–drug interaction studies using itraconazole as a CYP3A inhibitor and midazolam as a probe are standard and have successfully defined interactions for many drugs.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Madison, Wisconsin
- Fortea CRU Madison ( Site 0001) — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@merck.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.