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

NCT ID: NCT05700734

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2024-02-14

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.

Conditions

HIV-1; Human Immunodeficiency Virus 1; Immunodeficiency Virus Type 1, Human; Human Immunodeficiency Virus Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MK-8510

Intervention Type: DRUG

Single dose of MK-8510 administered as a tablet at a dose up to 2200 mg.

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.

Group Type: EXPERIMENTAL

MK-8510

Intervention Type: DRUG

Single dose of MK-8510 administered as a tablet at a dose up to 2200 mg.

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.

Group Type: EXPERIMENTAL

MK-8510

Intervention Type: DRUG

Single dose of MK-8510 administered as a tablet at a dose up to 2200 mg.

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.

Group Type: EXPERIMENTAL

MK-8510

Intervention Type: DRUG

Single dose of MK-8510 administered as a tablet at a dose up to 2200 mg.

Interventions

MK-8510

Single dose of MK-8510 administered as a tablet at a dose up to 2200 mg.

Intervention Type: DRUG

Eligibility 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:

1. Having never received any anti-retroviral agent; or

2. ART-experienced but has not received any ART for HIV-1 infection within 60 days; or

3. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-8510-002

Identifier Type: OTHER

Identifier Source: secondary_id

2021-006180-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8510-002

Identifier Type: -

Identifier Source: org_study_id