A Study of Rifabutin and MK-4646 in Healthy Participants (MK-4646-004)

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07199452
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • MK-4646 — DRUG
    Oral Capsule
  • Rifabutin — DRUG
    Oral Capsule

Study Details

Researchers have designed a new study medicine called MK-4646 as a new way to treat human immunodeficiency virus (HIV). Rifabutin is a medication used to treat tuberculosis (TB). Researchers want to learn about MK-4646 when taken at the same time as Rifabutin. They want to: Measure a person's blood to find out if the amount of MK-4646 in the blood is the same when MK-4646 is taken alone or with Rifabutin Learn about the safety of MK-4646 when taken alone or with Rifabutin and if people tolerate it

Key Dates

Start date
Oct 28, 2025
Status verified
Jan 2026
Primary completion
Dec 27, 2025
Completion
Jan 7, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: MK-4646
    On Period 1 Day 1, a single oral dose of MK-4646 will be administered.
  • Experimental: MK-4646 with Rifabutin
    Rifabutin will be administered orally once daily from Period 2 Day 1 through Period 2 Day 16. A single oral dose of MK-4646 will be administered on Period 2 Day 14.

Primary Outcome Measure

Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of MK-4646 in Plasma [ Time Frame: At designated timepoints (up to approximately 3 days post dose) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fortea CRU Madison ( Site 0001)MadisonWisconsin53704-

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