MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003)
NCT ID: NCT07042945
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
28 participants
INTERVENTIONAL
2025-07-09
2026-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MK-4646 Panel A
MK-4646 160 mg every 24 hours (q24h) for 7 days
MK-4646
MK-4646 in capsular form administered orally
MK-4646 Panel B
MK-4646 ≤460 mg q24h for 7 days
MK-4646
MK-4646 in capsular form administered orally
MK-4646 Panel C
MK-4646 ≤460 mg q24h for 7 days
MK-4646
MK-4646 in capsular form administered orally
MK-4646 Panel D
MK-4646 ≤460 mg every 12 hours (q12h) for 7 days
MK-4646
MK-4646 in capsular form administered orally
Interventions
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MK-4646
MK-4646 in capsular form administered orally
Eligibility Criteria
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Inclusion Criteria
* Is antiretroviral therapy (ART)-naïve
* If ART-experienced has not received any antiretroviral therapy within 60 days (or 5 half-lives, whichever is longer) prior to screening
* Is willing to receive no other ART prior to Day 8 post-dose of the trial
* If capable of producing sperm agrees to use contraception
* If assigned female sex at birth is not breastfeeding
* A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum), and uses a contraceptive method that is highly effective
Exclusion Criteria
* Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years.
* Has history of cancer (malignancy)
* Has history of significant multiple and/or severe allergies
* Tests positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies
* Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
* Has received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 14 days following study intervention
* Is unable to refrain from using protocol specified prohibited medications
* Is an excessive smoker, or consumes excessive amounts of alcoholic or caffeinated beverages
* Is a regular user of any illicit drugs or has a history of drug (including alcohol) abuse
18 Years
60 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002)
Chisinau, , Moldova
ARENSIA Exploratory Medicine ( Site 0001)
Bucharest, București, Romania
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-4646-003
Identifier Type: OTHER
Identifier Source: secondary_id
2025-521102-17-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1318-7985
Identifier Type: REGISTRY
Identifier Source: secondary_id
4646-003
Identifier Type: -
Identifier Source: org_study_id
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