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A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)

2 ноября 2026 г. обновлено: Merck Sharp & Dohme LLC

An Open-Label, Multiple-dose, Parallel Group Study to Evaluate the Pharmacokinetics of MK-6916 in Participants With Severe Renal Impairment and Moderate Renal Impairment

The purpose of this study is to learn what happens to MK-6916 in a person's body when given to participants with moderate or severe kidney impairment compared to healthy participants.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

32

Фаза

  • Фаза 1

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 80 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Moderate and Severe Renal Impairment

  • Except for severe or moderate renal impairment, is sufficiently healthy for study participation
  • Has stable renal function Healthy
  • Matches mean age to participants with moderate and severe renal impairment

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

All participants

  • Has history of cancer (malignancy)
  • Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)
  • Has had major surgery and/or donated or lost 1 unit of blood within 4 weeks prior to pretrial Participants with Renal Impairment
  • Has a history of renal artery stenosis, failed renal transplant or has had a nephrectomy, or end stage renal disease requiring dialysis

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Panel A: Severe Renal Impairment

Participants with severe renal impairment will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions.

Oral tablet

Экспериментальный: Panel B: Moderate Renal Impairment

Participants with moderate renal impairment will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions.

Oral tablet

Экспериментальный: Panel C: Healthy

Healthy participants will receive multiple doses of MK-6916 on Days 1-15 and a single oral dose on Day 16 under fasting conditions.

Oral tablet

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Area Under the Concentration-Time Curve from Time 0 to 12 Hours (AUC0-12) of MK-6916 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
AUC0-12 of MK-6916 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
Maximum Plasma Concentration (Cmax) of MK-6916 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Plasma Concentration at 12 Hours (C12) of MK-6916 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints(up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916.

Day 16: Predose and at designated timepoints(up to approximately 12 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of MK-6916 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Apparent Terminal Half-life (t1/2) of MK-6916 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the t1/2 of MK-6916.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Clearance at Steady State (CL,ss/F) of MK-6916 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the CL,ss/F of MK-6916.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Apparent Volume of Distribution at Steady State (Vz,ss/F) of MK-6916 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Vz,ss/F of MK-6916

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
AUC0-12 of MK-6916 Metabolite M5 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M5.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M9 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M9.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M10 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M10.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M5 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M5.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M9 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M9.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
AUC0-12 of MK-6916 Metabolite M10 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the AUC0-12 of MK-6916 M10.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
Cmax of MK-6916 Metabolite M5 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M5.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M5 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M5.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M9 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M9.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M9 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M9.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M10 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M10.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Cmax of MK-6916 Metabolite M10 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Cmax of MK-6916 M10.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
C12 of MK-6916 Metabolite M5 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M5.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M5 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M5.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M9 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M9.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M9 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M9.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M10 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M10.

Day 1: Predose and at designated timepoints (up to approximately 12 hours postdose)
C12 of MK-6916 Metabolite M10 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12 of MK-6916 M10.

Day 16: Predose and at designated timepoints (up to approximately 12 hours postdose)
Tmax of MK-6916 Metabolite M5 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M5.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M5 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M5.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M9 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M9.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M9 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M9.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M10 on Day 1
Временное ограничение: Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M10.

Day 1: Predose and at designated timepoints (up to approximately 336 hours postdose)
Tmax of MK-6916 Metabolite M10 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the Tmax of MK-6916 M10.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
t1/2 of MK-6916 Metabolite M5 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the t1/2 of MK-6916 M5.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
t1/2 of MK-6916 Metabolite M9 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the t1/2 of MK-6916 M9.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
t1/2 of MK-6916 Metabolite M10 on Day 16
Временное ограничение: Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)

Blood samples will be collected to determine the t1/2 of MK-6916 M10.

Day 16: Predose and at designated timepoints (up to approximately 336 hours postdose)
Number of Participants Who Experience an Adverse Event (AE)
Временное ограничение: Up to approximately 75 days

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

Up to approximately 75 days
Number of Participants Who Discontinue Study Treatment Due to an AE
Временное ограничение: Up to approximately 16 days

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

Up to approximately 16 days

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

  • Директор по исследованиям: Medical Director, Merck Sharp & Dohme LLC

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

11 декабря 2026 г.

Первичное завершение (Оцененный)

6 августа 2027 г.

Завершение исследования (Оцененный)

8 августа 2027 г.

Даты регистрации исследования

Первый отправленный

2 ноября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

2 ноября 2026 г.

Первый опубликованный (Действительный)

6 ноября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

6 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 ноября 2026 г.

Последняя проверка

1 октября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • 6916-013
  • MK-6916-013 (Другой идентификатор: MSD)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .