A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects

Официальное название

A Phase1 Study to Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects

Обзор

In this study, a single dose of \[14C\] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral \[14C\] HDM002.

Вмешательства

• Препарат [14C] HDM1002
  Administered orally

Первичные конечные точки

• Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] HDM1002 [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Metabolite profiling/identification in plasma, urine, and feces [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma and whole blood AUC[0-t] of radioactivity [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma and whole blood AUC[0-∞] of radioactivity [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma and whole blood Cmax of radioactivity [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma and whole blood Tmax of radioactivity [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma and whole blood t1/2 of radioactivity [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma and whole blood CL/F of radioactivity [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma and whole blood Vz/F of radioactivity [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Percentage of plasma HDM1002 and metabolites in total plasma radioactivity [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]

Вторичные конечные точки (8)

• Plasma AUC[0-t] of HDM1002 and metabolites [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma AUC[0-∞] of HDM1002 and metabolites [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma Cmax of HDM1002 and metabolites [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma Tmax of HDM1002 and metabolites [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma t1/2 of HDM1002 and metabolites [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma CL/F of HDM1002 and metabolites [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Plasma Vz/F of HDM1002 and metabolites [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]
• Adverse events (AEs) [Срок оценки: Predose up to Day 11 after administration of [14C] HDM1002]

Критерии участия

Критерии включения

• Male, healthy adult;
• Age of 18 to 45 years old (both inclusive);
• Body mass index (BMI) between 19.0- 32.0 kg/m2 (both inclusive) and body weight no less than 50.0 kg.

Критерии исключения

• Clinically significant diseases at the time of screening;
• History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin ≥ 35 ng/L during the screening period;
• History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening;
• History of acute cholecystitis attack within 3 months prior to screening;
• Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying or affect the absorption of nutrients in the gastrointestinal tract, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.;
• Any of the following: habitual constipation or diarrhea, hemorrhoids or accompanied by perianal disease, irritable bowel syndrome, inflammatory bowel disease, etc;
• Use of any prescription medication, over-the-counter medication, Chinese herbal medicine or food supplement within 14 days or 5 half-lives (whichever is longer) prior to the screening period;
• Patients with any abnormal and clinically significant examinations in given comprehensive physical examination;
• History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, metham phetamine, methylenedioxyamphetamine, cocaine) or positive urine drug test during the screening period;
• Positive for hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen/antibody combination test (HIV-Ag/Ab) and Treponema pallidum antibody during the screening period.
• Engaged in working conditions requiring long-term exposure to radioactivity; or significant radioactive exposure ( ≥ 2 CT chest/abdomen tests, or ≥ 3 all other types of X-rays test) within 1 year prior to the trail, or participated in radio-label trails;

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 First Affiliated Hospital of Soochow University — Сучжоу

Идентификаторы

NCT: NCT06576401 · HDM1002-104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗