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Набор скоро начнётся NCT07502001

Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin

Фаза I С лечением Overweight Obesity

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: Acetaminophen, Metformin, Warfarin, Atorvastatin.
Кому может быть актуально
Состояния в реестре: Overweight, Obesity. 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, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Influence of HDM1005 on Gastric Emptying and Drug-Drug Interaction of HDM1005 and Metformin, Atorvastatin, Warfarin, and Digoxin in Overweight/Obese Adult Chinese Subjects

Обзор

The purpose of this study is to characterize the Influence of HDM1005 on gastric emptying and drug-drug interaction of HDM1005 and metformin, atorvastatin, warfarin, and digoxin in overweight/obese adult subjects.

Вмешательства

  • Препарат Acetaminophen
    Single dose; Administered orally
  • Препарат Metformin
    Single dose; Administered orally
  • Препарат Warfarin
    Single dose; Administered orally
  • Препарат Atorvastatin
    Single dose; Administered orally
  • Препарат Digoxin
    Single dose; Administered orally
  • Препарат HDM1005 injection
    Subcutaneous injection QW

Первичные конечные точки

  • Area Under the Concentration Time Curve From Time Zero to ∞ [ AUC(0- ∞)] [Срок оценки: Up to Day 115]
  • Maximum observed concentration (Cmax) [Срок оценки: Up to Day 115]
  • Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] [Срок оценки: Up to Day 115]
  • Time of maximum observed concentration (Tmax) [Срок оценки: Up to Day 115]
Вторичные конечные точки (5)
  • Adverse events (AEs) [Срок оценки: Up to Day 115]
  • Apparent volume of distribution (Vz/F) [Срок оценки: Up to Day 115]
  • Time of maximum observed concentration (Tmax) [Срок оценки: Up to Day 115]
  • Maximum observed concentration (Cmax) [Срок оценки: Up to Day 115]
  • Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] [Срок оценки: Up to Day 115]

Критерии участия

Критерии включения

  • Aged between 18 and 45 years (inclusive), regardless of gender.
  • Male participants with body weight ≥50.0 kg, female participants with body weight ≥45.0 kg, and body mass index (BMI = weight \[kg\]/height² \[m²\]) within the range of 24.0 to 35.0 kg/m² (inclusive).
  • In the opinion of the investigator, participants are in generally good health based on medical history, clinical laboratory tests, vital signs, 12-lead ECG results, and physical examination findings at screening.
  • Provide signed informed consent form (ICF) prior to the trial, and have a thorough understanding of the trial content, procedures, and possible adverse reactions. Participants must be able to communicate well with the investigator, and understand and comply with the requirements of this study.

Критерии исключения

  • Participants with a medical history or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
  • History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
  • History of an acute episode of cholecystitis within 3 months prior to screening.
  • Experienced severe hypoglycemic events or recurrent hypoglycemic events (≥3 hypoglycemic events per week, or other hypoglycemic events as judged by the investigator) within 3 months prior to screening.
  • Blood donation, significant blood loss (≥400 mL), or use of blood products within 3 months prior to screening or between screening and the first dose.
  • Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications, whichever is longer (excluding contraceptives).
  • Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer).
  • Female participants who are breastfeeding or pregnant.
  • Participants with any other factors that, in the opinion of the investigator, make them unsuitable for participation in this trial (e.g., medical, psychological, or psychiatric conditions, social or geographical factors)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Second Affiliated Hospital of Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07502001 · HDM1005-104

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗