T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers
10 сентября 2021 г. обновлено: Corcept Therapeutics
A Randomized, Partial Double-Blind, Placebo- and Positive- Controlled, Multiple-Dose, 4-Way Crossover, Thorough QT/QTc (TQT) Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers
This dedicated T/QT study will investigate the effect of relacorilant on cardiac repolarization in healthy participants.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
This four-period crossover study with 12 treatment sequences includes relacorilant administered at therapeutic (400 mg once daily [QD]) and supra-therapeutic (800 mg QD) doses, placebo for relacorilant as a negative control, and oral moxifloxacin as a positive control.
The positive control will serve to determine the sensitivity of the assay to detect small increases from baseline in the QTc interval.
Each of the four treatment periods will last 5 days with a washout of at least 10 days between periods.
Relacorilant and placebo to relacorilant will be administered double-blind; moxifloxacin will be administered open label.
Тип исследования
Интервенционный
Регистрация (Действительный)
36
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
-
-
Missouri
-
Springfield, Missouri, Соединенные Штаты, 65802
- Single Site
-
-
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
Все
Описание
Inclusion Criteria:
- Participant with a BMI ≥18.0 kg/m^2 and ≤30.0 kg/m^2 at screening
- No clinically significant abnormal findings with the physical examination, medical/surgical/medication history, vital signs, or clinical laboratory assessments and adequate cardiac conduction by electrocardiogram (ECG) without evidence of first-, second- or third-degree atrioventricular block
- Female participants of childbearing potential with a negative serum pregnancy test at screening and urine pregnancy test on Day -1 of Period 1
- All male participants agree to use condom to prevent exposure to partner; male participants with female partner of childbearing potential to use a second method of contraception
- Female participants of childbearing potential agree to use the highly effective contraception of low user dependency
- Participant is willing and able to comply with all study procedures and restrictions
- Participant understands the study procedures and agrees to participate by providing written informed consent.
Exclusion Criteria:
- Participant with history or presence of any clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, endocrine, immunologic, dermatologic, neurological, psychiatric disease or disorder or any uncontrolled medical illness which in the opinion of the investigator would jeopardize the safety of the participant, interfere with study assessments, or impact the validity of the study results
- Participant with a history or family history of additional risk factors for Torsade de Pointe (TdP)
- Participant with a marked prolongation of ECG intervals, including QTcF >450 milliseconds (msec), PR >200 msec, or QRS >120 msec
- Participant with resting heart rate of <45beats per minute (bpm) or >100 bpm
- Participant with clinically significant abnormal ECG results
- Participant who uses medications that could prolong the QT/QTc interval
- Participant taking medications/dietary supplements that are highly dependent on cytochrome (CYP)3A for clearance and cannot undergo dose modification upon co-administration with strong CYP3A inhibitors
- Participant using any strong CYP3A inhibitor/inducer or any other medications prohibited per protocol
- Participant who is receiving testosterone within 40 days prior to study start
- Participant with a positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, or hepatitis C antibody
- Participant with a positive test result for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral RNA test, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19)
- Participant who has travelled abroad within 3 months prior to the screening visit or plans to travel abroad during the study
- Participant who has had a major surgery within the last 28 days prior to Screening
- Participant who received any investigational product within 30 days prior to Screening
- Participant who has a known or suspected allergy, or sensitivity to study products, or any of its ingredient(s), or to moxifloxacin
- Intolerance to repeated venipuncture or inability to swallow capsules
- Donation of blood within 56 days or plasma within 14 days prior to Screening or plans to donate during the entire study period
- Positive alcohol test and/or positive drugs of abuse screen or reports of a history of substance or alcohol abuse within 1 year prior to Screening
- Female participant who is pregnant, breastfeeding, or is planning to become pregnant during the entire study period
- Male participant with pregnant partner.
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: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Treatment Sequence 1
Participants will receive relacorilant 400 mg once daily (QD) for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 2
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 3
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 4
Participants will receive relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 5
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 6
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 7
Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 8
Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 9
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 10
Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 11
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
Экспериментальный: Treatment Sequence 12
Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Другие имена:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Placebo-corrected Change from Baseline in Cardiac QT Interval Corrected by Fridericia's Formula (QTcF)
Временное ограничение: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Change from Baseline in Cardiac QTcF
Временное ограничение: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Change from Baseline in Heart Rate (HR)
Временное ограничение: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Placebo-corrected Change from Baseline in HR
Временное ограничение: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Change from Baseline in Cardiac PR Interval
Временное ограничение: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Placebo-corrected Change from Baseline in Cardiac PR Interval
Временное ограничение: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Change from Baseline in Cardiac QRS Intervals
Временное ограничение: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Placebo-corrected Change from Baseline in Cardiac QRS Intervals
Временное ограничение: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
|
|
Number of Participants with a Categorical Outlier in QTcF
Временное ограничение: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
|
Number of Participants with a Categorical Outlier in HR
Временное ограничение: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
|
Number of Participants with a Categorical Outlier in PR Interval
Временное ограничение: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
|
Number of Participants with a Categorical Outlier in QRS Intervals
Временное ограничение: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
|
Number of Participants with a Treatment-emergent Change of T-wave Morphology
Временное ограничение: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
|
Number of Participants with a Treatment-emergent Presence of U-waves
Временное ограничение: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
|
|
Maximum Plasma Concentration (Cmax) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Временное ограничение: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
|
Time to Reach Cmax (Tmax) of Plasma Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Временное ограничение: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
|
Minimum Plasma Concentration (Cmin) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Временное ограничение: Before dosing on Day 5 of each treatment period
|
Before dosing on Day 5 of each treatment period
|
|
Area Under the Plasma-concentration Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Временное ограничение: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
|
Area Under the Plasma-concentration Curve from Time Zero to 24 Hours Postdose (AUC0-24) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Временное ограничение: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
|
|
Number of Participants with One or More Adverse Events
Временное ограничение: Up to Day 6 in each treatment period (up to 51 days)
|
Up to Day 6 in each treatment period (up to 51 days)
|
|
Number of Participants Discontinued From Study Treatment due to an Adverse Event
Временное ограничение: Up to Day 6 of each treatment period (up to 51 days)
|
Up to Day 6 of each treatment period (up to 51 days)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
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 (Действительный)
22 января 2021 г.
Первичное завершение (Действительный)
17 мая 2021 г.
Завершение исследования (Действительный)
13 июля 2021 г.
Даты регистрации исследования
Первый отправленный
29 января 2021 г.
Впервые представлено, что соответствует критериям контроля качества
11 марта 2021 г.
Первый опубликованный (Действительный)
12 марта 2021 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 сентября 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
10 сентября 2021 г.
Последняя проверка
1 сентября 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CORT125134-130
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Нет
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
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. .
Клинические исследования Здоровый
-
Biotie Therapies Inc.PRA Health Sciences; Tandem Labs; Xceleron IncЗавершенныйН/Д, как Healthy VolunteersНидерланды
-
Drugs for Neglected DiseasesSanofiЗавершенныйПК в Healthy VolunteersФранция
-
Newcastle UniversityЗавершенныйGI гликемический индекс здоровых добровольцев | Гликемическая нагрузка GL Healthy VolunteersСоединенное Королевство
-
CEN BiotechCEN Nutriment; Biovet Conseil; Amadeite SASЗавершенныйАнгедония в Healthy Volunteers
Клинические исследования Relacorilant
-
Corcept TherapeuticsЗавершенныйЗдоровыйСоединенные Штаты