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 — DRUGOral Capsule
- Rifabutin — DRUGOral 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-4646On Period 1 Day 1, a single oral dose of MK-4646 will be administered.
- Experimental: MK-4646 with RifabutinRifabutin 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fortea CRU Madison ( Site 0001) | Madison | Wisconsin | 53704 | - |
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