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NCT05700734 | Withdrawn | HIV-1

MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)
Sponsor:

Merck Sharp & Dohme LLC

Brief Summary:

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants.

Condition or disease

HIV-1

Human Immunodeficiency Virus 1

Immunodeficiency Virus Type 1, Human

Human Immunodeficiency Virus Type 1

Intervention/treatment

MK-8510

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 0 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-retroviral Activity of MK-8510 Monotherapy in Anti-retroviral-naïve HIV-1 Infected Participants
Actual Study Start Date : April 17, 2023
Estimated Primary Completion Date : February 14, 2024
Estimated Study Completion Date : February 14, 2024
Arm Intervention/treatment

Experimental: Panel A: MK-8510 at dose level 1

Single oral dose of MK-8510 administered at dose level 1 (≤1800 mg) following a 10-hour fast. Dose level 1 shall not exceed 1800 mg.

Friend: MK-8510

Experimental: Panel B: MK-8510 at dose level 2

Single oral dose of MK-8510 administered at dose level 2 (≤2200 mg) following a 10-hour fast. Dose level 2 shall not exceed 2200 mg.

Friend: MK-8510

Experimental: Panel C: MK-8510 at dose level 3

Single oral dose of MK-8510 administered at dose level 3 (≤2200 mg) following a 10-hour fast. Dose level 3 shall not exceed 2200 mg.

Friend: MK-8510

Experimental: Panel D: MK-8510 at dose level 4

Single oral dose of MK-8510 administered at dose level 4 (≤2200 mg) following a 10-hour fast. Dose level 4 shall not exceed 2200 mg.

Friend: MK-8510
Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Has HIV-1 infection, and is in good health based on medical history, physical examination, vital signs (VS) measurements, and laboratory safety tests.
  • Has documented HIV-1 positive, as determined by a positive enzyme-linked immunosorbent assay (ELISA) or real-time quantitative polymerase chain reaction (QT-PCR) with confirmation (eg, Western Blot).
  • Is anti-retroviral therapy (ART)-naïve, which is defined as
    • Having never received any anti-retroviral agent; or
    • ART-experienced but has not received any ART for HIV-1 infection within 60 days; or
    • Has received pre-exposure prophylaxis (PrEP) treatment prior to diagnosis of HIV-infection but has not received any PrEP within 30 days.
    • Is willing to receive no other ART prior to Day 11 post-dose of the study.
    • Has a body mass index (BMI) ≤35 kg/m2.
    Exclusion Criteria
    • Has acute (primary) HIV-1 infection.
    • Has a 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.
    • Has remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma).
    • Is mentally or legally incapacitated or has significant emotional problems.
    • Has history of cancer (malignancy).
    • Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e, systemic allergic reaction) to prescription or nonprescription drugs or food.
    • Has positive hepatitis B surface antigen (HBsAg).
    • Has a history of chronic hepatitis C unless there has been documented cure and/or participant with a positive serologic test for hepatitis C virus (HCV) has a negative HCV viral load (VL).
    • 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 participated in another investigational study within 4 weeks.
    • Has a clinically significant abnormality on the electrocardiogram (ECG) performed at the pre-study visit.
    • Has been committed to an institution by way of official or judicial order.
    • Is under the age of legal consent or not capable of giving consent.
    • Does not agree to follow the smoking restrictions as defined by the clinical research unit (CRU).
    • Consumes greater than 3 servings of alcoholic beverages (1 serving is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day.
    • Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
    • Is a regular user of any illicit drugs (not including cannabis) or has an history of drug (including alcohol) abuse within approximately 12 months.
MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)

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MK-8510 Monotherapy for the Treatment of Anti-retroviral naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8510-002)

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