- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02342574
F901318 Multiple Ascending Dose Study
F901318 - A Phase I, Double-Blind, Placebo Controlled, Single and Multiple Ascending Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Double blind, placebo controlled, ascending single and multiple intravenous dose, sequential group study. This will be a study in two parts. In the first part, up to twenty four subjects will complete the study in up to 3 cohorts (Groups A to C), each group consisting of 8 subjects, six of whom will receive active compound and two will receive placebo for eight days. Each subject will be on study for approximately 7 weeks. Each subject will participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 13 (120 hours post the last dose).
This first part (Part 1) will test doses already evaluated in the previous single ascending dose study (F901318-01-01-14, 0.25-4 mg/kg given over 4 hours). The dose levels for the study are expected to be 1.5, 3 and 4 mg/kg/day given as a four hour infusion once daily.
In the second part of the study (Part 2), doses higher than those previously evaluated may be studied and/or different dosing schedules designed to deliver a maximum tolerated dose over 24 hours. If a dose level higher than those previously studied is chosen, there will be an optional single dose studied initially for safety and pharmacokinetic profile (Part 2A), followed about 14 days later in another group of subjects by exposure at that same dose level over 8 consecutive days (Part 2B). These higher doses may be given in a once or twice daily dosing schedule. Six subjects will receive active compound and two will receive placebo in both the single dose and multiple dose cohorts. The single dose cohorts will receive study drug in a sentinel group design in which two subjects receive study drug (one active and one placebo) on the first day and the rest of the group one day later. There will be a review of safety data by the Principal Investigator and the Medical Monitor after the first two subjects have been dosed and before the last six subjects are dosed in each cohort in part 2A.
In Part 2, up to forty-eight subjects will complete the study in up to 6 cohorts (Part 2A, Groups D1 to F1, single day dosing, and Part 2B, Groups D2 to F2 eight days' dosing). Subjects in Parts 1 and 2B will be on the study for approximately 7 weeks and Part 2A for approximately 8 weeks. Each subject will participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 6 (120 hours after the single dose in Parts 1 and 2A) and from Day -1 (the day before dosing) to Day 13 (120 hours after the first dose in Part 2B). The proposed total daily dose levels for Part 2 will be up to 10 mg/kg/day given either once daily or in two split daily doses. The duration of the infusions will be between 2 and 24 hours which may include a loading dose to achieve therapeutic plasma concentrations as quickly as possible.
All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 1
Контакты и местонахождение
Места учебы
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-
UK
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London, UK, Соединенное Королевство, NW10 7EW
- Hammersmith Medicines Research
-
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-100 kg inclusive
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable)
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
- Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function
Exclusion Criteria:
- Male subjects who are not willing to use appropriate contraception (such as a condom) during the study and until follow up
- Subjects who have received any prescribed systemic or topical medication within 14 days of dosing with study drug unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of dosing with study drug (with the exception of vitamin/mineral supplements and paracetamol) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of dosing with study drug unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
- Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical or biological entity) in the past 3 months since the last dose.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: A active
Six subjects receiving F901318 1.5 mg/kg intravenously for eight days
|
Administration of active compound
|
Плацебо Компаратор: A placebo
Two subjects receiving F901318 placebo intravenously for eight days
|
Администрация плацебо
|
Экспериментальный: B active
Six subjects receiving F901318 3 mg/kg intravenously for eight days
|
Administration of active compound
|
Плацебо Компаратор: B placebo
Two subjects receiving F901318 placebo intravenously for eight days
|
Администрация плацебо
|
Экспериментальный: C active
Six subjects receiving F901318 4 mg/kg intravenously for eight days
|
Administration of active compound
|
Плацебо Компаратор: C placebo
Two subjects receiving F901318 placebo intravenously for eight days
|
Администрация плацебо
|
Экспериментальный: D1 active
Six subjects dosed for one day with F901318 intravenously dose to be determined
|
Administration of active compound
|
Плацебо Компаратор: D1 placebo
Two subjects receiving F901318 placebo intravenously for one day
|
Администрация плацебо
|
Экспериментальный: E1 active
Six subjects dosed for one day with F901318 intravenously dose to be determined
|
Administration of active compound
|
Плацебо Компаратор: E1 placebo
Two subjects receiving F901318 placebo intravenously for one day
|
Администрация плацебо
|
Экспериментальный: F1 active
Six subjects dosed for one day with F901318 intravenously dose to be determined
|
Administration of active compound
|
Плацебо Компаратор: F1 placebo
Two subjects receiving F901318 placebo intravenously for one day
|
Администрация плацебо
|
Экспериментальный: D2 active
Six subjects dosed for eight days with F901318 intravenously dose to be determined
|
Administration of active compound
|
Плацебо Компаратор: D2 placebo
Two subjects receiving F901318 placebo intravenously for eight days
|
Администрация плацебо
|
Экспериментальный: E2 active
Six subjects dosed for eight days with F901318 intravenously dose to be determined
|
Administration of active compound
|
Плацебо Компаратор: E2 placebo
Two subjects receiving F901318 placebo intravenously for eight days
|
Администрация плацебо
|
Экспериментальный: F2 active
Six subjects dosed for eight days with F901318 intravenously dose to be determined
|
Administration of active compound
|
Плацебо Компаратор: F2 placebo
Two subjects receiving F901318 placebo intravenously for eight days
|
Администрация плацебо
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
safety: adverse events
Временное ограничение: 13 days
|
adverse events
|
13 days
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
pharmacokinetics AUC
Временное ограничение: 13 days
|
area under concentration time curve
|
13 days
|
pharmacokinetics Cmin
Временное ограничение: 13 days
|
drug level in blood 24 hours after dosing
|
13 days
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Frans van den Berg, MB ChB, Hammersmith Medicines Research
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- F901318-01-02-14
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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