A Mass Balance Study of [14C]ABSK011 in Healthy Adult Male Chinese Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)
研究概览
简要总结
This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK011 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects to ensure at least 6 evaluable subjects.
详细描述
Participants will be screened no more than 14 days before the dose (D-14 through D-3) and admitted to the clinical trial unit 2 days before the dose (D-2). Participants will receive a single oral administration of approximately 200 mg/120 µCi [14C]ABSK-011 suspension after a low-fat breakfast on day 1 morning.
Urine and stool samples will be collected from participants before and at specified intervals between 0 and 192 hours after taking the drug and blood samples will be collected at specified time points between 0 and 120 hours before and after taking the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants who fully understand the content, procedures and possible adverse reactions before the study, and voluntarily sign the informed consent form, and can complete the study in accordance with the requirements in the protocol;
- •Healthy male participants aged 18 to 45 years (including 18 and 45 years) at screening;
- •Weight ≥ 50 kg, body mass index (BMI) between 19 and 26 (including 19 and 26), BMI = weight (kg)/height (m) ^2;
- •Participants must have regular defecation in the past three months;
- •Male participants of childbearing potential must agree to use effective contraceptive methods during the study and within 6 months after administration of study drug . Male subjects must agree to not donate sperm during this period.
排除标准
- •Abnormal and clinically significant complete physical examination, vital signs, digital rectal examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, stool routine + occult blood, thyroid function, etc.), 12-lead electrocardiogram, chest X-ray (anteroposterior position), abdominal B ultrasound (hepatobiliary, pancreas, spleen and kidney);
- •Tested positive for any one of the following: serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, treponema pallidum antibody (Syphilis) screening;
- •The baseline of heart rate corrected QT, QTcF interval prolongs ≥450ms; family history of long QT syndrome (Note: QTc interval is corrected by Fridericia formula);
- •Known or persistent mental disorders that may interfere with the subject's participation in the study, as judged by the investigator;
- •Known history of allergy to any drug or food;
- •Participants who have participated in drug trials within 3 months before dosing.
- •Participants who have participated in this study or any other study related to ABSK011, and have previously exposed to ABSK011;
- •Known history of drug abuse or tested positive in drug abuse screening;
- •Participants with any other factors that may influence the participation in the study, which may affect the subject's compliance with the protocol, interfere with the interpretation of the study results, or expose the subject to risk, as judged by the investigator.
研究组 & 干预措施
[14C]ABSK011
Participants will receive a single oral administration of approximately 200 mg/120 µCi [14C]ABSK-011 suspension after a low-fat breakfast on day 1 morning.
干预措施: [14C]ABSK011 (Drug)
结局指标
主要结局
Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)
时间窗: All excreted urine and feces samples at specified time points during 0-192 hours after dosing will be collected.
To assess the routes and rates of elimination of ABSK011 and its metabolites after single oral administration of \[14C\]ABSK011 in healthy adult male subjects
Percentage of each metabolite in urine and feces relative to the administered dose (% administered dose), or percentage of metabolites in plasma relative to total exposure AUC (% AUC);
时间窗: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol
To determine the metabolism and elimination pathways of ABSK011 after single oral administration of \[14C\] ABSK011 in healthy adult male subjects, and identify major metabolites.All excreted urine and feces samples at specified time points during 0-192 hours after dosing will be collected.
%AUC
时间窗: Conduct testing within 1 month after all subjects collect all samples at all time points required by the protocol
To evaluate the pharmacokinetics of ABSK011 and its major metabolites in the urine of healthy adult male subjects after a single oral administration \[14C\] of ABSK011.
次要结局
- Frequency, type and severity of adverse events/serious adverse events; changes in vital signs, 12-lead ECGs, laboratory tests, etc.(From signing the ICF until 9 days after the first dosing)