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Идёт набор NCT07082829

A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age

Фаза I С лечением Excessive Daytime Sleepiness

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: ORX142 Tablets, Placebo Tablets.
Кому может быть актуально
Состояния в реестре: Excessive Daytime Sleepiness. Базовые параметры: 18 лет — 80 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 Randomized, Double-blind, Sponsor-open, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of ORX142 in Healthy Adults, Single Doses of ORX142 in Healthy Older Adults, and a Single Dose Crossover, Proof-of-concept Study of ORX142 in Acutely Sleep-deprived Healthy Subjects

Обзор

Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.

Вмешательства

  • Препарат ORX142 Tablets
    ORX142 Tablets
  • Другое Placebo Tablets
    Placebo Tablets

Первичные конечные точки

  • Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects [Срок оценки: From enrollment to the Follow-Up Visit 13 days post-discharge]
  • Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states [Срок оценки: From enrollment to the Follow-Up Visit 13 days post-discharge]
  • Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects [Срок оценки: From enrollment to the Follow-Up Visit 13 days post-discharge]
  • Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects [Срок оценки: From enrollment to the Follow-Up Visit 13 days post-discharge]
  • Part E: Incidence and severity of Treatment-Emergent Adverse Events of oral of single oral doses of ORX142 in acutely sleep-deprived healthy adult subjects [Срок оценки: From enrollment to the Follow-Up Visit 13 days post-discharge]
Вторичные конечные точки (10)
  • Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 [Срок оценки: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 [Срок оценки: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142 [Срок оценки: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142 [Срок оценки: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 in the fasted and fed state. [Срок оценки: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state [Срок оценки: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state [Срок оценки: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142 in the fast and fed state [Срок оценки: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX142 versus placebo. [Срок оценки: Part E: Day 2]
  • Karolinska Sleepiness Scale score for ORX142 versus placebo [Срок оценки: Part E: Day 1-2]

Критерии участия

Критерии включения

  • Healthy males or females as determined by assessments at the Screening Visit.

For Parts A, B, C, and E:

a. Participants must be at least 18 years of age and no more than 55 years of age at the Screening

  • For Part D:

a .Participants must be at least 60 years of age and no more than 80 years of age at the Screening

Критерии исключения

  • Presence of significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological, or psychiatric disease, as determined by medical history, physical examination, and screening investigations.
  • History of seizure disorder, any other condition that increases the risk of seizure
  • Has a clinically significant sleep disorder, including insomnia or sleep apnea.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • Site #1 — Lincoln
  • Site #2 — Eatontown
  • Site #3 — New York

Идентификаторы

NCT: NCT07082829 · ORX142-0101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗