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Идёт набор NCT07661108

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

Фаза I С лечением Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MK-8527, Probenecid, Itraconazole.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Fortrea Clinical Research Unit Inc ( Site 0001) — Daytona Beach

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗