A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects.

Официальное название

A Phase I, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of HDM1002 on the Pharmacokinetics of Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy and Overweight Adult Chinese Subjects

Обзор

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

Вмешательства

• Препарат Repaglinide
  Single dose; Administered orally
• Препарат Atorvastatin
  Single dose; Administered orally
• Препарат Digoxin
  Single dose; Administered orally
• Препарат Rosuvastatin
  Single dose; Administered orally
• Препарат HDM1002
  Administered orally

Первичные конечные точки

• AUC[0-∞] [Срок оценки: Period 1 and Period 3: Day 1-Day 16]
• AUC[0-t] [Срок оценки: Period 1 and Period 3: Day 1-Day 16]
• Cmax [Срок оценки: Period 1 and Period 3: Day 1-Day 16]

Вторичные конечные точки (5)

• Tmax [Срок оценки: Period 1 and Period 3: Day 1-Day 16]
• t1/2 [Срок оценки: Period 1 and Period 3: Day 1-Day 16]
• CL/F [Срок оценки: Period 1 and Period 3: Day 1-Day 16]
• Vz/F [Срок оценки: Period 1 and Period 3: Day 1-Day 16]
• Adverse events (AEs) [Срок оценки: Period 1 and Period 3: Day 1-Day 16, Period 2: Day 1-Day 35]

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.
• Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).

Критерии исключения

• Subject 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 attack within 3 months prior to screening.
• Subject 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

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06601517 · HDM1002-106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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