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

First listed
Feb 27, 2026
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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