A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin

Официальное название

A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Drug-Drug Interaction of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin in Overweight/Obese Adult Chinese Subjects

Обзор

The purpose of this study is to characterize the drug-drug intereaction of HDM1002 and metformin, empagliflozin, midazolam, valsartan, and warfarin in overweight/obese adult subjects. The safety and tolerability of HDM1002 with metformin, empagliflozin, midazolam, valsartan, and warfarin when given separately or together will also be evaluated

Вмешательства

• Препарат Metformin
  Administered orally
• Препарат Empagliflozin
  Single dose; Administered orally
• Препарат Midazolam
  Single dose; Administered orally
• Препарат Valsartan
  Single dose; Administered orally
• Препарат Warfarin
  Single dose; Administered orally
• Препарат HDM1002
  Administered orally

Первичные конечные точки

• AUC[0-∞] [Срок оценки: through study completion, an average of 11 weeks]
• Cmax [Срок оценки: through study completion, an average of 11 weeks]
• AUC[0-t] [Срок оценки: through study completion, an average of 11 weeks]

Вторичные конечные точки (3)

• PK parameter of HDM1002 [Срок оценки: through study completion, an average of 11 weeks]
• other PK parameters [Срок оценки: through study completion, an average of 11 weeks]
• Adverse events (AEs) [Срок оценки: through study completion, an average of 11 weeks]

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.
• Subject weighed ≥50.0 kg, and a body mass index (BMI) within the range of 24.0 - 35.0 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.
• Severe hypoglycemic events or recurrent hypoglycemic events occurred 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.
• Any pre-existing conditions that increase the risk of bleeding, such as acute gastritis or active ulcers with bleeding, hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, and active pathological bleeding, 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

• The Second Affiliated Hospital of Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07331389 · HDM1002-111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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