A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007)
Part of paid clinical trials in Madison, Wisconsin.
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT07435194
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 24 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- MK-2828 — DRUGAdministered orally as capsule
- Itraconazole — DRUGAdministered orally as syrup
- Midazolam — DRUGAdministered orally as syrup
Study Details
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.
Key Dates
- Start date
- Mar 6, 2026
- Status verified
- Mar 2026
- Primary completion
- Aug 12, 2026
- Completion
- Aug 12, 2026
Study Design
- Enrollment
- 28 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Part 1: ItraconazoleParticipants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828.
- Experimental: Part 2: MidazolamParticipants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam.
Primary Outcome Measure
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 ]
Central Contacts
- Toll Free Number1-888-577-8839
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fortea CRU Madison ( Site 0001) | Madison | Wisconsin | 53704 | Study Coordinator 608-210-5454 |
Find similar trials in Madison, WI
Related Studies
- Fully Automated High-Throughput Quantitative MRI of the LiverRecruiting · University of Wisconsin, Madison · Madison, Wisconsin
- The ENHANCE Study: taVNS and PsilocybinPHASE1 · Recruiting · University of Wisconsin, Madison · Madison, Wisconsin
- Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study Stage 1Recruiting · University of Wisconsin, Madison · Madison, Wisconsin
- Neuromodulation-assisted Ego-disengagement: The NEURO-EGO Study Stage 2Recruiting · University of Wisconsin, Madison · Madison, Wisconsin