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Идёт набор NCT07156201

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ABS-1230 Given Orally Compared With Placebo in Healthy Participants Aged 18 to 55 Years

Фаза I С лечением KCNT1-Related Epilepsy

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: ABS-1230, Placebo, Omeprazole, Voriconazole.
Кому может быть актуально
Состояния в реестре: KCNT1-Related Epilepsy. 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
Австралия
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 First-in-Human, Phase 1a, Randomized, Double-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose and Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABS-1230 Administered Orally to Healthy Adults

Обзор

This first in human trial will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses, multiple ascending doses, and fed and fasted doses of ABS-1230 given orally compared with placebo in adult healthy participants.

Подробное описание

This is a Phase 1a, first-in-human, placebo-controlled study consisting of 3 parts.

Part 1 is a single ascending dose (SAD) study in up to 40 participants consisting of a screening period of up to 28 days prior to a single dose of ABS-1230 or placebo, with follow-up 7 days and 14 days after dosing.

Part 2 is a multiple ascending dose (MAD) study in up to 30 participants consisting of a screening period of up to 28 days, followed by ABS-1230 or placebo once daily for 14 days, with follow-up 7 days and 14 days after dosing is completed.

Part 3 is a food effect (FE) study in 12 participants consisting of two doses of ABS-1230 under fasted and fed conditions and in combination with omeprazole with follow-up 7 days and 14 days after dosing is completed.

Part 4 is a drug-drug interaction (DDI) study in 10 participants consisting of doses of ABS-1230 in combination with voriconazole, with follow-up 15 days after dosing is completed.

Вмешательства

  • Препарат ABS-1230
    ABS-1230
  • Препарат Placebo
    Placebo
  • Препарат Omeprazole
    Omeprazole
  • Препарат Voriconazole
    Voriconazole

Первичные конечные точки

  • Safety and tolerability (incidence, severity, and dose-relationship of adverse events) [Срок оценки: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)]
  • Safety and tolerability (incidence, severity, and dose-relationship of clinically significant changes in laboratory parameters) [Срок оценки: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)]
Вторичные конечные точки (8)
  • Maximum Plasma Concentration [Cmax] After Single Dose of ABS-1230 [Срок оценки: Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)]
  • Maximum Plasma Concentration [AUCinf] After Single Dose of ABS-1230 [Срок оценки: Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)]
  • Maximum Plasma Concentration [Cmax] After Multiple Doses of ABS-1230 [Срок оценки: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)]
  • Maximum Plasma Exposure [AUCtau] After Multiple Doses of ABS-1230 [Срок оценки: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)]
  • Maximum Plasma Concentration [Cmax] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230 [Срок оценки: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)]
  • Maximum Plasma Exposure [AUCtau] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230 [Срок оценки: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)]
  • Maximum Plasma Concentration [Cmax] of ABS-1230 in Combination with Voriconazole [Срок оценки: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)]
  • Maximum Plasma Exposure [AUCtau] of ABS-1230 in Combination with Voriconazole [Срок оценки: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)]

Критерии участия

Критерии включения

  • Age 18 to 55 years, inclusive
  • Body mass index greater than or equal to 18 to less than or equal to 32 kg/m2
  • Medically healthy with no clinically significant medical history, physical examination, vital sign, standard 12-lead ECG, chemistry, hematology, urinalysis, or coagulation results at Screening as deemed by the Investigator
  • Male and female subjects must use adequate birth control and agree not to donate sperm or eggs for the time periods specified in the protocol

Критерии исключения

  • Positive result for HIV, HBV, or HCV
  • History of malignancy other than treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix
  • History of alcoholism or recreational drug use within 2 years or a positive alcohol or tobacco test result at screening or first check-in visit
  • For female participants, must not be pregnant, breastfeeding, or seeking to become pregnant while in the study

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Австралия · 1 центр
  • Scientia Clinical Research — Sydney

Идентификаторы

NCT: NCT07156201 · ABS1230-1001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗