A Study of Solid Formulations of JNJ-39393406 in Healthy Male Participants
11 ноября 2013 г. обновлено: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-Label, Single Dose, Relative Bioavailability Study of Solid Formulations in Fed and Fasted Conditions Followed by a Repeated Dose Study of a Selected Solid Formulation of JNJ-39393406 in Healthy Male Subjects
The purpose of the study is to compare the pharmacokinetics (what a medication does to the body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations in Part 1; based on the profile in Part 1, one of the formulations assessed will be selected to investigate the pharmacokinetics in fasting condition in Part 2 and after repeated dosing in Part 3.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
This is an open-label (all people know the identity of the intervention) and single center study that will be conducted in 3 parts (Part 1, Part 2, and Part 3).
The study consists of 3 phases including, the screening phase, treatment phase, and the follow-up phase.
Part 1 is a four-way cross-over (method used to switch participants from one treatment arm to another in a clinical study) study to compare the pharmacokinetics, dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations (X and Y).
Approximately 12 participants will be enrolled in Part 1. Part 2 is two-way cross-over study in a separate group of participants to assess pharmacokinetics in fasting condition and the relative bioavailability (the extent to which a medication or other substance becomes available to the body) of the selected solid formulation from Part 1 compared with a solution formulation.
Approximately 8 participants will be enrolled in Part 2. In Part 3, the single and repeated dose pharmacokinetics after administration of the selected formulation from Part 1 will be assessed for 7 consecutive days.
The same participants will participate in Parts 2 and 3 of the study.
Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, and neurological examination.
The duration of participation in the study for an individual participant will be approximately 8 weeks (including screening and follow up visit).
Тип исследования
Интервенционный
Регистрация (Действительный)
20
Фаза
- Фаза 1
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Antwerp, Бельгия
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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 55 лет (Взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Мужской
Описание
Inclusion Criteria:
- Healthy male participants
- Body mass index (BMI) between 18 and 30 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
- Willing to adhere to the prohibitions and restrictions specified in the protocol
- Must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening or admission
- Clinically significant abnormal physical examination, neurological examination, vital signs or 12 lead electrocardiogram at screening
- Significant history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, dyspnea, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers clinically significant
- Significant history of or current psychiatric or neurological illness
- Serology positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies at screening
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: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Part 1; Period 1
Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks.
30 mg of solid X, 120 mg of solid Y, 30 mg of solid Y, and 120 mg of solid X.
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Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
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Экспериментальный: Part 1; Period 2
Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks.
30 mg of solid Y, 30 mg of solid X, 120 mg of solid X and 120 mg of solid Y.
|
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
|
|
Экспериментальный: Part 1; Period 3
Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid X, 30 mg of solid Y, 120 mg of solid Y, and 30 mg of solid X.
|
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
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Экспериментальный: Part 1; Period 4
Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid Y, 120 mg of solid X, 30 mg of solid X, and 30 mg of solid Y.
|
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
|
|
Экспериментальный: Part 2; Period 1
Four participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solid formulation, and 30 mg of solution.
|
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
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Экспериментальный: Part 2; Period 2
Four participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solution, and 30 mg of solid formulation.
|
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
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Экспериментальный: Part 3
Eight participants (same participants from Part 2) will receive JNJ 39393406 (dose will likely be 30 mg, or another multiple of the 30 mg solid dose form selected in Part 1, but not higher than 210 mg) from Days 1 to 7.
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Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Maximum plasma concentration of JNJ 39393406
Временное ограничение: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
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Maximum plasma concentration of JNJ 39393406, determined by visual inspection of the data
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Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
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Time to reach the maximum plasma concentration of JNJ 39393406
Временное ограничение: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
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Time to reach the maximum plasma concentration, determined by visual inspection of the data
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Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
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Area under the plasma concentration-time curve of JNJ-39393406
Временное ограничение: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3
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Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3
|
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Number of participants with adverse events
Временное ограничение: Up to 7 to 14 days after last dose of study medication (Part 1, Part 2, and Part 3)
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Up to 7 to 14 days after last dose of study medication (Part 1, Part 2, and Part 3)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Директор по исследованиям: Johnson & Johnson Pharmaceutical Research & Development Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 мая 2009 г.
Первичное завершение (Действительный)
1 августа 2009 г.
Завершение исследования (Действительный)
1 августа 2009 г.
Даты регистрации исследования
Первый отправленный
11 ноября 2013 г.
Впервые представлено, что соответствует критериям контроля качества
11 ноября 2013 г.
Первый опубликованный (Оценивать)
18 ноября 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
18 ноября 2013 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 ноября 2013 г.
Последняя проверка
1 ноября 2013 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- CR016264
- 39393406EDI1003 (Другой идентификатор: Johnson & Johnson Pharmaceutical Research & Development)
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. .