MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07042945
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • MK-4646 — DRUG
    MK-4646 in capsular form administered orally

Study Details

This study will examine if at least one dose level of MK-4646 can lower HIV-1 viral load in a person's blood by a certain amount. The goals of this study are to learn about the safety of MK-4646 and if people tolerate it; and how HIV-1 viral load may decrease after starting to take MK-4646.

Key Dates

Start date
Jul 9, 2025
Status verified
May 2026
Primary completion
Jul 8, 2026
Completion
Aug 17, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MK-4646 Panel A
    MK-4646 160 mg every 24 hours (q24h) for 7 days
  • Experimental: MK-4646 Panel B
    MK-4646 ≤460 mg q24h for 7 days
  • Experimental: MK-4646 Panel C
    MK-4646 ≤460 mg q24h for 7 days
  • Experimental: MK-4646 Panel D
    MK-4646 ≤460 mg every 12 hours (q12h) for 7 days

Primary Outcome Measure

Participants with averse events (AEs) [ Time Frame: 14 days post last dose (Up to Day 23) ]

Central Contacts

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