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

NCT05700734 | Withdrawn Phase 1 FDA Drug

• 3 other identifiers: 8510-002MK-8510-0022021-006180-21
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)

  The plasma HIV-RNA will be measured based on a longitudinal data analysis model containing fixed effects for dose level, and dose level by time interaction, and a random effect of MK-8510 (prodrug). The change from baseline for each dose level at 168-hours post baseline will be estimated from this model.

  Baseline and 168 hours post-dose

• Percentage of Participants Who Experience an Adverse Event (AE)

  An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  Up to 36 days

• Percentage of Participants Who Discontinued from Study Due to an Adverse Event (AE)

  The percentage of participants who discontinue study due to an AE will be presented.

  Up to 36 days

Secondary Outcomes (9)

• Area Under the Concentration-Time Curve of MK-8558 From Time 0 to 168 Hours (AUC0-168 hr)

  At protocol specific timepoints up to 168 hours post-dose

• Area Under the Concentration-Time Curve of MK-8558 From Time 0 to last (AUC0-last)

  At protocol specific time points up to 504 hours post-dose

• Concentration at 168 Hours Post-dose (C168) of MK-8558

  168 hours post-dose

• Maximum Concentration (Cmax) of MK-8558

  At protocol specific time points up to 504 hours post-dose

• Time to Maximum Plasma Concentration (Tmax) of MK-8558

  At protocol specific time points up to 504 hours post-dose

Study Arms (4)

Panel A: MK-8510 at dose level 1

EXPERIMENTAL

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.

Drug: MK-8510

Panel B: MK-8510 at dose level 2

EXPERIMENTAL

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.

Drug: MK-8510

Panel C: MK-8510 at dose level 3

EXPERIMENTAL

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.

Drug: MK-8510

Panel D: MK-8510 at dose level 4

EXPERIMENTAL

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.

Drug: MK-8510

Interventions

MK-8510 DRUG

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

Panel A: MK-8510 at dose level 1; Panel B: MK-8510 at dose level 2; Panel C: MK-8510 at dose level 3; Panel D: MK-8510 at dose level 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: April 17, 2023
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share