- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00918632
Food Effect Study Of AG-013736 In Healthy Volunteers
A Phase I Open-Label Study In Healthy Volunteers To Compare The Plasma Pharmacokinetics of Polymorph Form XLI AG-013736 In The Fasted And Fed State
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 1
Контакты и местонахождение
Места учебы
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Bruxelles, Бельгия, 1070
- Pfizer Investigational Site
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead Electrocardiogram (ECG) and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject or a legally acceptable representative.
Exclusion Criteria:
- Evidence of history of clinically significant blood, kidney, endocrine, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- Active smokers or users of other tobacco products as well as users of certain drugs.
- Pregnant or nursing females; females of childbearing potential, including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory Follicle-stimulating hormone (FSH) test results at Screening.
Учебный план
Как устроено исследование?
Детали дизайна
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Другой: Sequence 1 (ABC)
The following treatments will be administered in the following order A -> B-> C
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A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> B -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> C -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of an FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> C -> A. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> A -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> A -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> B -> A. Each of these treatments will be separated by a 7 day washout period.
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Другой: Sequence 2 (ACB)
The following treatments will be administered in the following order A -> C -> B
|
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> B -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> C -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of an FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> C -> A. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> A -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> A -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> B -> A. Each of these treatments will be separated by a 7 day washout period.
|
Другой: Sequence 3 (BCA)
The following treatments will be administered in the following order B -> C -> A
|
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> B -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> C -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of an FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> C -> A. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> A -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> A -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> B -> A. Each of these treatments will be separated by a 7 day washout period.
|
Другой: Sequence 4 (BAC)
The following treatments will be administered in the following order B -> A -> C
|
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> B -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> C -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of an FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> C -> A. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> A -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> A -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> B -> A. Each of these treatments will be separated by a 7 day washout period.
|
Другой: Sequence 5 (CAB)
The following treatments will be administered in the following order C -> A -> B
|
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> B -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> C -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of an FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> C -> A. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> A -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> A -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> B -> A. Each of these treatments will be separated by a 7 day washout period.
|
Другой: Sequence 6 (CBA)
The following treatments will be administered in the following order C -> B -> A
|
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> B -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> C -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of an FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> C -> A. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> A -> C. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> A -> B. Each of these treatments will be separated by a 7 day washout period.
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> B -> A. Each of these treatments will be separated by a 7 day washout period.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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To assess the effect of a high-fat, high-calorie meal and overnight fasting on polymorph Form XLI AG-013736 plasma pharmacokinetics following a single 5 mg oral dose in healthy volunteers.
Временное ограничение: 2 months
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2 months
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
To assess the effect of a moderate-fat, standardized meal and overnight fasting on polymorph Form XLI AG-013736 plasma pharmacokinetics following a single 5 mg oral dose in healthy volunteers.
Временное ограничение: 2 months
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2 months
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To assess the safety and tolerability of single-dose polymorph Form XLI AG-013736 when administered with a high-fat, high-calorie meal, a moderate-fat, standard-calorie meal and overnight fasting in healthy volunteers.
Временное ограничение: 2 months
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2 months
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- A4061053
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. .
Клинические исследования Здоровые волонтеры
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Drugs for Neglected DiseasesSanofiЗавершенныйПК в Healthy VolunteersФранция
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Biotie Therapies Inc.PRA Health Sciences; Tandem Labs; Xceleron IncЗавершенныйН/Д, как Healthy VolunteersНидерланды
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Newcastle UniversityЗавершенныйGI гликемический индекс здоровых добровольцев | Гликемическая нагрузка GL Healthy VolunteersСоединенное Королевство
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CEN BiotechCEN Nutriment; Biovet Conseil; Amadeite SASЗавершенныйАнгедония в Healthy Volunteers
Клинические исследования AG-013736
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Arog Pharmaceuticals, Inc.ОтозванКарцинома немелкоклеточного легкого
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PfizerЗавершенныйМеланома | Кожные новообразованияСоединенные Штаты, Франция
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PfizerЗавершенныйНовообразования почек | Карцинома, почечно-клеточнаяСоединенные Штаты
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University Health Network, TorontoPfizerЗавершенныйГепатоцеллюлярная карциномаКанада
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PfizerЗавершенный
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National Cancer Institute (NCI)ЗавершенныйФеохромоцитома | ПараганглиомаСоединенные Штаты
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PfizerЗавершенныйНовообразования почекКорея, Республика, Соединенные Штаты, Канада, Испания, Италия, Соединенное Королевство, Китай, Сингапур, Словакия, Франция, Япония, Австралия, Германия, Тайвань, Бразилия, Российская Федерация, Индия, Польша, Австрия, Греция, Ирл... и более
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PfizerЗавершенныйМиелодиспластический синдром | Острый миелоидный лейкоз (ОМЛ)Соединенные Штаты
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Memorial Sloan Kettering Cancer CenterPfizer; National Comprehensive Cancer NetworkЗавершенныйАденоидно-кистозная карциномаСоединенные Штаты
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University of Michigan Rogel Cancer CenterЗавершенныйПлоскоклеточный рак головы и шеиСоединенные Штаты