A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants.
16 июня 2014 г. обновлено: Janssen R&D Ireland
A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GSK2336805 (Part 1), Followed by an Open-label, Randomized, 4-way Crossover Study to Evaluate Short-term Safety, Tolerability and Pharmacokinetics of the Co-administration of TMC435 and GSK2336805 at Steady-state (Part 2), in Healthy Japanese Subjects
The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (what the body does to a medication) of GSK2336805 alone and with the co-administration of TMC435 in healthy Japanese participants.
Обзор исследования
Статус
Статус
Завершенный
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Подробное описание
This study will consists of 2 parts (Part 1 and 2) which will be sequentially conducted in 2 separate panels of 24 healthy adult Japanese participants each, at a single center.
Part 1 is a double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (placebo is compared with the study medication to test whether the study medication has a real effect in clinical study), randomized (study medication is assigned by chance), single ascending dose study to investigate the safety, tolerability, and pharmacokinetics of GSK2336805 in participants.
It will consist of a screening phase, a treatment phase, and a follow-up phase.
The maximum study duration for each participant will be approximately 5 weeks (including screening and follow-up phase).
24 participants will be equally divided in 3 cohorts with 8 participants in each cohort.
In each cohort, participants will be randomly assigned to receive either a single oral dose of GSK2336805 (6 participants) or placebo (2 participants).
Part 2 is an open-label (all people know the identity of the intervention), randomized, 4-way crossover study (method used to switch patients from one treatment arm to another in a clinical study) to investigate the potential pharmacokinetic drug-drug interactions between TMC435 and GSK2336805 at steady-state, and to evaluate the short-term safety and tolerability when TMC435 and GSK2336805 are co-administered in participants.
It will consist of a screening phase, a treatment phase (4 treatment sessions [Treatment A, B, C, and D]), and a follow-up phase.
The maximum study duration for each participant will be approximately 12 weeks (including screening and follow-up phase).
During 4 treatment sessions, each of the 24 participants will receive Treatment A, B, C and D consecutively in different sequences with a washout period of at least 7 days between consecutive treatment sessions in each individual participant.
Safety will be evaluated by assessing adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, alcohol breath tests, and specific toxicities.
Тип исследования
Тип исследования
Интервенционный
Регистрация (Действительный)
Регистрация
48
Фаза
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
-
-
California
-
Cypress, California, Соединенные Штаты
-
-
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
Критерии приемлемости
Возраст, подходящий для обучения
От 20 лет до 55 лет (Взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Healthy Japanese participants on the basis of medical history, physical examination, vital signs, triplicate 12-lead electrocardiogram, and clinical laboratory testing performed at screening
- Must have signed an Informed Consent Form (ICF) indicating they understand the purpose of and procedures required for the study
- Must be willing to adhere to the prohibitions and restrictions specified in the protocol
- Women must be of non-childbearing potential (postmenopausal for at least 2 years or surgically sterile)
- Women, except for postmenopausal women, should have a negative serum b-human chorionic gonadotropin (hCG) pregnancy test at screening
Exclusion Criteria:
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use within the past one year
- Participants with hepatitis A, B, or C infection or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study screening
- Female participants who are breastfeeding at screening
- History of liver or renal impairment; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
- Participants with known allergies, hypersensitivity, or intolerance to GSK2336805, TMC435 or excipients of the drug products used
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: Тройной
Количество рук
7
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
|
Экспериментальный: Part 1, Cohort A
8 participants to receive a single oral dose of 30 mg of GSK2336805 (6 participants) or placebo (2 participants) on Day 1.
|
A single dose of 1 tablet of 30 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.
|
|
Экспериментальный: Part 1, Cohort B
8 participants to receive a single oral dose of 60 mg of GSK2336805 (6 participants) or placebo (2 participants) on Day 1.
|
A single dose of 2 tablets of 30 mg ie, 60 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.
|
|
Экспериментальный: Part 1, Cohort C
8 participants to receive a single oral dose of 120 mg of GSK2336805 (6 participants) or placebo (2 participants) on Day 1.
|
A single dose of 4 tablets of 30 mg ie, 120 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.
|
|
Экспериментальный: Part 2, Sequence 1
6 participants to receive Treatment A (TMC435 150 mg), D (TMC435 150 mg+GSK2336805 60 mg), B (GSK2336805 60 mg), and C (TMC435 100 mg+GSK2336805 60 mg) in a sequence with a 7 days washout period between each treatment sessions.
|
1 capsule of TMC435 150 mg taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
2 tablets of 30 mg GSK2336805 ie, 60 mg of GSK2336805 taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
1 capsule of TMC435 100 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
1 capsule of TMC435 150 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
|
|
Экспериментальный: Part 2, Sequence 2
6 participants to receive Treatment B (GSK2336805 60 mg), A (TMC435 150 mg), C (TMC435 100 mg+GSK2336805 60 mg), and D (TMC435 150 mg+GSK2336805 60 mg) in a sequence with a 7 days washout period between each treatment sessions.
|
1 capsule of TMC435 150 mg taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
2 tablets of 30 mg GSK2336805 ie, 60 mg of GSK2336805 taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
1 capsule of TMC435 100 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
1 capsule of TMC435 150 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
|
|
Экспериментальный: Part 2, Sequence 3
6 participants to receive Treatment C (TMC435 100 mg+GSK2336805 60 mg), B (GSK2336805 60 mg), D (TMC435 150 mg+GSK2336805 60 mg), and A (TMC435 150 mg) in a sequence with a 7 days washout period between each treatment sessions.
|
1 capsule of TMC435 150 mg taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
2 tablets of 30 mg GSK2336805 ie, 60 mg of GSK2336805 taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
1 capsule of TMC435 100 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
1 capsule of TMC435 150 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
|
|
Экспериментальный: Part 2, Sequence 4
6 participants to receive Treatment D (TMC435 150 mg+GSK2336805 60 mg), C (TMC435 100 mg+GSK2336805 60 mg), A (TMC435 150 mg) and B (GSK2336805 60 mg) in a sequence with a 7 days washout period between each treatment sessions.
|
1 capsule of TMC435 150 mg taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
2 tablets of 30 mg GSK2336805 ie, 60 mg of GSK2336805 taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
1 capsule of TMC435 100 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
1 capsule of TMC435 150 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
|
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Part 1: Maximum observed plasma concentration of GSK2336805
Временное ограничение: Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal
|
Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal
|
|
Part 1: Area under the plasma concentration-time curve of GSK2336805
Временное ограничение: Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal
|
Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal
|
|
Part 1: The actual sampling time to reach the maximum observed plasma concentration of GSK2336805
Временное ограничение: Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal
|
Predose, postdose on Day 1 (0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 hours), Day 2 (24 and 36 hour), Day 3, and time point of early withdrawal
|
|
Part 2: Maximum observed plasma concentration of TMC435
Временное ограничение: Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
|
Part 2: Area under the plasma concentration-time curve of TMC435
Временное ограничение: Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
|
Part 2: The actual sampling time to reach the maximum observed plasma concentration of TMC435
Временное ограничение: Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
|
Part 2: Maximum observed plasma concentration of GSK2336805
Временное ограничение: Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
|
Part 2: Area under the plasma concentration-time curve of GSK2336805
Временное ограничение: Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
|
Part 2: The actual sampling time to reach the maximum observed plasma concentration of GSK2336805
Временное ограничение: Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
Predose, postdose on Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 2, Day 5, Day 6, Day 7 (predose and postdose (0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours), Day 8, Day 9, Day 10, and time point of early withdrawal
|
Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Part 1 and 2: Number of participants with adverse events
Временное ограничение: Up to 12-14 weeks
|
Number of participants with adverse events as a measure of safety and tolerability after administration of TMC435 alone, GSK2336805 alone, and after TMC435 administration in combination with GSK2336805
|
Up to 12-14 weeks
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Спонсор
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
Начало исследования
1 октября 2013 г.
Первичное завершение (Действительный)
Первичное завершение
1 марта 2014 г.
Завершение исследования (Действительный)
Завершение исследования
1 марта 2014 г.
Даты регистрации исследования
Первый отправленный
Первый отправленный
17 декабря 2013 г.
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
17 декабря 2013 г.
Первый опубликованный (Оценивать)
Первый опубликованный
23 декабря 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее опубликованное обновление
17 июня 2014 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
16 июня 2014 г.
Последняя проверка
Последняя проверка
1 июня 2014 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- CR102928
- TMC435HPC1012 (Другой идентификатор: Janssen R&D Ireland)
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. .