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Completed

NCT Number: NCT07042945

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 0002), Chisinau, Moldova

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Other than having HIV-1, is in good health
  • 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 acute (primary) HIV-1 infection
  • 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

Treatment and study plan

MK-4646

Drug

MK-4646 in capsular form administered orally

Primary outcomes

  1. Participants with averse events (AEs)

    Time frame: 14 days post last dose (Up to Day 23)

    Percentage of participants with one or more AEs

  2. Participants who discontinued study medication due to an AE

    Time frame: Up to Day 7

    Percentage of participants who discontinued study medication due to an AE

  3. Viral load decline of plasma HIV-1 ribonucleic acid (RNA)

    Time frame: Predose, 1,2, 3, 4 and 5 days postdose

    Time course of plasma HIV-1 RNA viral load decline.

Secondary outcomes

  1. Area under the curve from time 0 to 24 hours (AUC0-24) of MK-4646

    Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose

    AUC0-24 postdose of plasma MK- 4646 in the fasted state

  2. Maximum plasma concentration (Cmax) of MK-4646

    Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose

    Cmax postdose of plasma MK- 4646 in the fasted state

  3. Concentration at 24 hours (C24) of MK-4646

    Time frame: 24 hours postdose

    C24 postdose of plasma MK- 4646 in the fasted state

  4. Time to maximum concentration (Tmax) of MK-4646

    Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose

    Tmax postdose of plasma MK- 4646 in the fasted state

  5. Half life (t1/2) of MK-4646

    Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose

    T1/2 postdose of plasma MK- 4646 in the fasted state

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of MK-4646 Monotherapy in Antiretroviral Therapy-Naïve Participants With HIV-1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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