[¹⁴C] Hydronidone Mass Balance Study

Официальное название

[¹⁴C] Hydronidone Mass Balance Study in Chinese Healthy Adult Male Participants

Обзор

According to the "Technical Guidelines for Radioactive Labeled Human Mass Balance Studies" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it is recommended that mass balance studies be conducted for all new molecular entities. Therefore, to further clarify the absorption, metabolism, and excretion characteristics of Hydronidone in the human body, a \[¹⁴C\] Hydronidone mass balance study is planned in Chinese healthy adult male participants. This study aims to reveal the pharmacokinetic characteristics of Hydronidone and provide a reference for the rational use of the drug.

Вмешательства

• Препарат [¹⁴C]Hydronidone
  Enrolled participants fasted for at least 10 hours prior to dosing. On the morning of Day 1 (D1), a single oral dose of \[¹⁴C\]Hydronidone suspension (containing approximately 90 mg/100 μCi of \[¹⁴C\]Hydronidone) was administered under fasting conditions, with approximately 240 mL of water used for preparation and administration. Except for the water used for dosing, no water was permitted within 1 hour before and after administration. Participants remained in the isotope ward of the study cente

Первичные конечные точки

• Cumulative radioactive recovery in excreta (urine and feces) per collection period [Срок оценки: within 9 days after dosing]
• Cumulative total radioactive recovery in excreta (urine and feces) [Срок оценки: within 9 days after dosing]
• Pharmacokinetic parameters of total radioactivity in plasma : Cmax [Срок оценки: within 9 days after dosing]
• Pharmacokinetic parameters of total radioactivity in plasma : Tmax [Срок оценки: within 9 days after dosing]
• Pharmacokinetic parameters of total radioactivity in plasma : t1/2 [Срок оценки: within 9 days after dosing]
• Pharmacokinetic parameters of total radioactivity in plasma : MRT [Срок оценки: within 9 days after dosing]
• Pharmacokinetic parameters of total radioactivity in plasma : AUC [Срок оценки: within 9 days after dosing]
• Whole blood ratio of total radioactivity concentration [Срок оценки: within 9 days after dosing]
• plasma ratio of total radioactivity concentration [Срок оценки: within 9 days after dosing]
• Percentage of unchanged drug relative to total radioactivity exposure in plasma [Срок оценки: within 9 days after dosing]

Критерии участия

Критерии включения

• Participants must be fully informed about the study, understand the study content, procedures, and potential adverse events related to the investigational drug, and voluntarily sign a written informed consent form;
• Chinese adult male participants aged 18 to 50 years (inclusive);
• Participants weighing at least 50 kg at screening, with a body mass index \[BMI = weight (kg) / height² (m²)\] within the range of 19.0 to 26.0 kg/m² (inclusive);
• Participants have no plan to donate sperm within 6 months after dosing; participants and their partners have no pregnancy plan during the study and within 6 months after dosing, and voluntarily agree to use effective contraceptive measures (see Appendix 1 for details; contraceptive pills are prohibited for participants during the study) to avoid pregnancy of the participant's partner.

Критерии исключения

• The researcher determines that there are other diseases or medical histories that are clinically significant or may interfere with the participant's ability to comply with the study protocol and complete the study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, mental system, and endocrine metabolic system;
• Abnormalities in vital signs, physical examination, routine laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (anterior view), abdominal ultrasound, etc., at screening or baseline, which are determined by the researcher to be clinically significant;
• Results from the 12-lead electrocardiogram at screening or baseline showing QTcF ≥ 450ms, or other abnormal electrocardiogram indicators that are clinically significant;
• Positive results for any of the following: quantitative determination of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen/antibody;
• Any surgical procedure that may affect drug metabolism and excretion (such as cholecystectomy, except for appendectomy), or plans to undergo surgery during the trial period;
• A previous diagnosis of Gilbert's syndrome;
• Hemorrhoids with bloody stools or perianal diseases with regular or ongoing bloody stools; severe nausea or vomiting within one week before screening; habitual constipation or diarrhea; or positive fecal occult blood test;
• Use of any prescription drugs, over-the-counter medications, vitamin products, or herbal remedies within 14 days or 5 half-lives (whichever is longer) prior to dosing; use of strong inhibitors or inducers of UGTs, SULTs, CYP3A4, P-gp, breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, or OAT1/3, or any drugs known to prolong the QT/QTc interval or carry a risk of causing torsade de pointes (TdP) within 4 weeks before screening (see Appendix 2 for details); or plans to use any chemical drugs, biologics, traditional Chinese medicines, or natural products during the trial that the researcher deems unsuitable;
• A history of drug allergies or allergic diseases (such as asthma, urticaria, eczematous dermatitis), or a suspected or confirmed allergy to the trial drug (including similar drugs) or any of its excipients as determined by the researcher;
• Participants with rare genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption;
• Participation in any other clinical trial drug or interventional clinical study within 3 months before screening;
• Blood donation or blood loss ≥ 400 mL within 3 months before dosing, or blood transfusion or use of blood products within 4 weeks before dosing;
• Difficulty in blood collection or intolerance to venous blood sampling.
• Individuals who work with long-term exposure to radioactive conditions, or those with significant radioactive exposure within 1 year prior to screening (≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations), or those who have participated in radiolabeled drug trials within 1 year prior to screening;
• History of drug abuse or substance abuse, or positive urine drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid, methylenedioxymethamphetamine);
• Average weekly alcohol consumption of ≥14 units within 3 months prior to screening (1 unit ≈ 360 mL beer, or 45 mL liquor, or 150 mL wine), or positive breath alcohol test;
• Average daily smoking of >5 cigarettes (or equivalent nicotine products) within 3 months prior to dosing, or inability to discontinue any tobacco products during the study, or positive cotinine test;
• Habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL), and inability to abstain during the study; or consumption of any chocolate, caffeine, or xanthine-rich foods or beverages within 48 hours prior to dosing;
• Vaccination within 4 weeks prior to dosing, or planned vaccination within 1 month after dosing;
• Other reasons deemed by the investigator as making the participant unsuitable for this study.

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

• Beijing Gaobo Hospital — Пекин

Идентификаторы

NCT: NCT07471217 · KDN-F351-202506

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗