A Phase 1, First-in-human Study of VX-433
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: VX-433, Placebo, Midazolam, Bupropion.
- Кому может быть актуально
- Состояния в реестре: Narcolepsy Type 1 (NT1). Базовые параметры: 18 лет — 55 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 1, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VX-433 and Its Effects on the Pharmacokinetics of Midazolam and Bupropion
Обзор
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-433 following single and multiple ascending doses, as well as to assess the effect of VX-433 on the PK of midazolam, bupropion, and hydroxybupropion.
Подробное описание
The study is being conducted in healthy participants to evaluate the safety, tolerability, and PK of VX-433 (Parts A and B), as well as potential drug-drug interaction (DDI) between VX-433 and midazolam or bupropion (Part C).
Note: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Вмешательства
- Препарат VX-433
Suspension for Oral Administration - Препарат Placebo
Suspension for Oral Administration - Препарат Midazolam
Syrup for Oral Administration - Препарат Bupropion
Capsule for Oral Administration
Первичные конечные точки
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From Day 1 up to Day 6]
- Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From Day 1 up to Day 18]
- Part C: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-433 [Срок оценки: From Day 1 up to Day 22]
- Part C: Maximum Observed Plasma Concentration (Cmax) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433 [Срок оценки: From Day 1 up to Day 22]
- Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-433 [Срок оценки: From Day 1 up to Day 22]
- Part C: Area Under the Concentration Versus Time Curve (AUC) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433 [Срок оценки: From Day 1 up to Day 22]
Вторичные конечные точки (11)
- Part A: Maximum Observed Plasma Concentration (Cmax) of VX-433 [Срок оценки: From Day 1 up to Day 6]
- Part B: Maximum Observed Plasma Concentration (Cmax) of VX-433 [Срок оценки: From Day 1 up to Day 18]
- Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-433 [Срок оценки: From Day 1 up to Day 6]
- Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-433 [Срок оценки: From Day 1 up to Day 18]
- Part A: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1/2) [Срок оценки: From Day 1 up to Day 6]
- Part B: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1/2) [Срок оценки: From Day 1 up to Day 18]
- Part A: Renal Clearance (CLr) of VX-433 [Срок оценки: From Day 1 up to Day 2]
- Part B: Renal Clearance (CLr) of VX-433 [Срок оценки: From Day 1 up to Day 11]
- Part A: Amount of VX-433 excreted in Urine [Срок оценки: From Day 1 up to Day 2]
- Part B: Amount of VX-433 excreted in Urine [Срок оценки: From Day 1 up to Day 11]
- Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From Day 1 up to Day 29]
Критерии участия
Критерии включения
- Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m2), inclusive
- A total body weight of more than (>) 50 kg
- Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening
Критерии исключения
- History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- Any condition possibly affecting drug absorption
- For female participants: of childbearing potential, pregnant, breastfeeding, or planning to become pregnant or donate ova during the study or within 90 days after last dose of study drug
Other protocol defined Inclusion/Exclusion criteria will apply.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- ICON - Utah - Salt Lake City Office — Salt Lake City
Идентификаторы
NCT: NCT07584434 · VX25-433-001