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Recruiting NCT07661108

A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MK-8527, Probenecid, Itraconazole.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants

Overview

Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults. The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.

Interventions

  • Drug MK-8527
    Oral tablet
  • Drug Probenecid
    Oral tablet
  • Drug Itraconazole
    Oral solution

Primary outcome measures

  • Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
  • Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
  • Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
Secondary outcome measures (12)
  • Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
  • Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
  • Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
  • Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
  • Part 1: Number of Participants Who Experience an Adverse Event (AE) [Time frame: Up to approximately 43 days]
  • Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 43 days]
  • Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
  • Part 2: Tmax of MK-8527 in Plasma with and without Probenecid [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
  • Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
  • Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid [Time frame: Predose and at designated timepoints (up to 336 hours postdose)]
  • Part 2: Urine Concentration at 72 Hours of MK-8527 [Time frame: At designated timepoints (up to 72 hours postdose)]
  • Part 2: Renal Clearance of MK-8527 [Time frame: At designated timepoints (up to 72 hours postdose)]

Eligibility criteria

Inclusion criteria

  • Be in good health
  • Has a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive

Exclusion criteria

  • Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m\^2
  • 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 a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
  • Has a history of cancer (malignancy)
  • Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Fortrea Clinical Research Unit Inc ( Site 0001) — Daytona Beach

Identifiers

NCT: NCT07661108 · 8527-021 · MK-8527-021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗