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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05700734
Other study ID # 8510-002
Secondary ID MK-8510-0022021-
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date April 17, 2023
Est. completion date February 14, 2024

Study information

Verified date March 2023
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 14, 2024
Est. primary completion date February 14, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Area Under the Concentration-Time Curve of MK-8558 From Time 0 to 168 Hours (AUC0-168 hr) The AUC0-168 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168 hours post-dose. At protocol specific timepoints up to 168 hours post-dose
Secondary Area Under the Concentration-Time Curve of MK-8558 From Time 0 to last (AUC0-last) AUC0-last of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose. At protocol specific time points up to 504 hours post-dose
Secondary Concentration at 168 Hours Post-dose (C168) of MK-8558 C168hr of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated. 168 hours post-dose
Secondary Maximum Concentration (Cmax) of MK-8558 Cmax of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose. At protocol specific time points up to 504 hours post-dose
Secondary Time to Maximum Plasma Concentration (Tmax) of MK-8558 Tmax of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose. At protocol specific time points up to 504 hours post-dose
Secondary Half Life (t1/2) of MK-8558 t1/2 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose. At protocol specific time points up to 504 hours post-dose
Secondary Apparent Plasma Clearance of Drug After Extravascular Administration (CL/F) of MK-8558 CL/F of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose. At protocol specific time points up to 504 hours post-dose
Secondary Apparent Volume of Distribution in the Terminal State After Extravascular Administration (Vz/F) of MK-8558 Vz/F of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose. At protocol specific time points up to 504 hours post-dose
Secondary Terminal t1/2 of MK-8558 Terminal t1/2 of MK-8558 (active drug) after administration of MK-8510 (prodrug) in plasma will be calculated pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 24, 48, 72, 120, 168, 240, 336, 504 hours post-dose. At protocol specific time points up to 504 hours post-dose
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