A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
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
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 1
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
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
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
Спонсор
Следователи
- Директор по исследованиям: Medical Director, Merck Sharp & Dohme LLC
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 6916-013
- MK-6916-013 (Другой идентификатор: MSD)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .