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A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)

9 февраля 2015 г. обновлено: Merck Sharp & Dohme LLC

A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Subjects With Renal Insufficiency

This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees of renal insufficiency.

Обзор исследования

Статус

Прекращено

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

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 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Male or nonpregnant female age 18 to 75 years
  • Female of childbearing potential on appropriate method of contraception
  • Body mass index (BMI) less than or equal to 40 kg/m2
  • Participant is in good health
  • Participant diagnosed with Type 2 Diabetes
  • Participant agrees to follow smoking restrictions
  • Willing to follow the study diet restrictions

Exclusion Criteria:

  • Mental or legal incapacitation
  • Participant has had kidney removed
  • History of Type 1 diabetes
  • History of stroke, chronic seizures or major neurological disorder
  • History of neoplastic disease
  • Nursing mother
  • Consumes greater than 4 glasses of alcoholic beverages per day
  • Consumes greater than 6 servings of caffeinated beverages per day
  • Participant has had surgery or donated 1 unit of blood within 1 month of screening
  • Participant has history of recent eye infection within 2 weeks of study drug administration
  • Clinically diagnosed with glaucoma or blindness
  • Has trauma to one or both eyes

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: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: MK-0941 20 mg Mild Renal Insufficiency
MK-0941 20 mg administered to participants with mild renal insufficiency and type 2 diabetes.
Лекарство: MK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
Экспериментальный: MK-0941 20 mg Moderate Renal Insufficiency
MK-0941 20 mg administered to participants with moderate renal insufficiency and type 2 diabetes.
Лекарство: MK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
Экспериментальный: MK-0941 5 mg Severe Renal Insufficiency
MK-0941 5 mg administered to participants with severe renal insufficiency and type 2 diabetes.
Лекарство: MK-0941 5 mg
MK-0941 administered as one single 5-mg tablet.
Экспериментальный: MK-0941 20 mg Matched Controls
MK-0941 20 mg administered to age-, gender-, race-, body mass index (BMI)-, and hemoglobin A1C (HbAIc)-matched control subjects with normal renal function and type 2 diabetes.
Лекарство: MK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
Экспериментальный: MK-0941 5 mg Matched Controls
MK-0941 5 mg administered to age-, gender-, race-, body mass index (BMI)-, and HbAIc-matched control subjects with normal renal function and type 2 diabetes.
Лекарство: MK-0941 5 mg
MK-0941 administered as one single 5-mg tablet.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls
Временное ограничение: 72 Hours Post-Dose
Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of > 50 to 80 mL/min/1.73m^2.
72 Hours Post-Dose
Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.
72-Hours Post-Dose
Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.
72-Hours Post-Dose

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.
72-Hours Post-Dose
Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.
72-Hours Post-Dose
Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.
72-Hours Post-Dose
Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.
72-Hours Post-Dose
Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.
72-Hours Post-Dose
Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.
72-Hours Post-Dose
Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.
72-Hours Post-Dose
T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.
72-Hours Post-Dose
T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls
Временное ограничение: 72-Hours Post-Dose
T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.
72-Hours Post-Dose
Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls
Временное ограничение: 36-Hours Post-Dose
Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.
36-Hours Post-Dose
Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls
Временное ограничение: 36-Hours Post-Dose
Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.
36-Hours Post-Dose
Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls
Временное ограничение: 36-Hours Post-Dose
Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.
36-Hours Post-Dose
CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls
Временное ограничение: 36-Hours Post-Dose
CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.
36-Hours Post-Dose
CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls
Временное ограничение: 36-Hours Post-Dose
CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.
36-Hours Post-Dose
CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls
Временное ограничение: 36-Hours Post-Dose
CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.
36-Hours Post-Dose
Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls
Временное ограничение: Up to 12 Hours Post-Dose
The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.
Up to 12 Hours Post-Dose
Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls
Временное ограничение: Up to 12 Hours Post-Dose
The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to < 50 mL/min/1.73m^2.
Up to 12 Hours Post-Dose
Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls
Временное ограничение: Up to 12 Hours Post-Dose
The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.
Up to 12 Hours Post-Dose

Соавторы и исследователи

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

Спонсор

Merck Sharp & Dohme LLC

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

1 января 2009 г.

Первичное завершение (Действительный)

1 сентября 2009 г.

Завершение исследования (Действительный)

1 сентября 2009 г.

Даты регистрации исследования

Первый отправленный

26 января 2009 г.

Впервые представлено, что соответствует критериям контроля качества

26 января 2009 г.

Первый опубликованный (Оценивать)

28 января 2009 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

26 февраля 2015 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 февраля 2015 г.

Последняя проверка

1 февраля 2015 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 0941-015
  • 2009_522

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

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

Нет

продукт, произведенный в США и экспортированный из 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. .

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