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 — DRUG
    Administered orally as capsule
  • Itraconazole — DRUG
    Administered orally as syrup
  • Midazolam — DRUG
    Administered 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: Itraconazole
    Participants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828.
  • Experimental: Part 2: Midazolam
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Fortea CRU Madison ( Site 0001)MadisonWisconsin53704
Study Coordinator
608-210-5454

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