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Набор скоро начнётся NCT06562088

A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects

Фаза I С лечением Healthy Adult Subject

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: HDM1002 and rifampicin, HDM1002 and itraconazole.
Кому может быть актуально
Состояния в реестре: Healthy Adult Subject. Базовые параметры: 18 лет — 45 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
Китай
Следующий шаг
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Официальное название

A Phase I, Open-Label, Parallel, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of Rifampicin or Itraconazole on the Pharmacokinetics of HDM1002 in Healthy Adult Chinese Subjects

Обзор

The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.

Вмешательства

  • Препарат HDM1002 and rifampicin
    Administered orally
  • Препарат HDM1002 and itraconazole
    Administered orally

Первичные конечные точки

  • AUC[0-∞] of HDM1002 [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • AUC[0-24 h] of HDM1002 [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • Cmax of HDM1002 [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • AUC[0-t] of HDM1002 [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • Tmax of HDM1002 [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • t1/2 of HDM1002 [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • CL/F of HDM1002 [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • Vz/F of HDM1002 [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
Вторичные конечные точки (9)
  • AUC[0-∞] of HDM1002 metabolites [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • AUC[0-24 h] of HDM1002 metabolites [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • Cmax of HDM1002 metabolites [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • AUC[0-t] of HDM1002 metabolites [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • Tmax of HDM1002 metabolites [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • t1/2 of HDM1002 metabolites [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • CL/F of HDM1002 metabolites [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • Vz/F of HDM1002 metabolites [Срок оценки: Cohort 1: Day 1-Day 5 and Day 12-Day 16; Cohort 2: Day 1-Day 5 and Day 9-Day 13]
  • Adverse events (AEs) [Срок оценки: Cohort 1: Day 1-Day 16; Cohort 2: Day 1-Day 13]

Критерии участия

Критерии включения

  • According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
  • Age range of 18-45 years old (including range), no limit to gender.
  • Eligible male participant weighed ≥50.0 kg, eligible female participant weighed ≥45.0 kg, and had a body mass index (BMI) within the range of 19.0 - 32.0 kg/m2 (including cut-off values).

Критерии исключения

  • Participant has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
  • History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
  • History of acute cholecystitis within 3 month prior to initiation of screening period.
  • Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
  • History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
  • During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
  • Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
  • History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
  • Presence of clinically significant ECG results judged by the investigator at screening.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The second hospital of anhui medical university — Хэфэй

Идентификаторы

NCT: NCT06562088 · HDM1002-105

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗