the Material Balance and Biotransformation Study of [14C] XZP-3287 in Healthy Chinese Male Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PK data for 14C-XZP-3287: Cmax
研究概览
简要总结
A single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] XZP-3287
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Healthy adult males aged 18 to 45 years (inclusive).
- •Body weight ≥ 50 kg for males; body mass index (BMI) in the range 19-26 kg/m2 (inclusive).
- •No mental disorders, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities.
- •No clinically significant vital signs, physical examination, laboratory tests, ECG findings.
- •No plans to have children within the last 12 months, and willing to use effective contraception within 12 months after the end of dosing.
- •Subjects are able to communicate well with the investigators, and be able to complete the trial according to the process, and sign an Informed Consent Form.
排除标准
- •Subjects with a history of drug allergy, or atopic allergic disease (Asthma, urticaria, eczema dermatitis), or a known history of allergy to the test drug or its adjuvant components.
- •History of clinically significant ECG abnormalities or family history of long QT syndrome.
- •History of any significantly diseases affect drug absorption, distribution, metabolism, and excretion.
- •Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive.
- •Positive results from urine drug screen test.
- •Donate blood or lose blood 200 mL or more within 1 month prior to dosing.
- •Subjects who have used any medication, herbal medicine, nutritional supplements or health care products within 4 weeks prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication.
- •History of needles or blood fainting, or have difficulty in blood collection, or cannot tolerate venipuncture for blood collection.
研究组 & 干预措施
[14C]XZP-3287
Eligible healthy male subjects received a single oral 360 mg (radioactivity of 50µCi) dose of [14C]XZP-3287
干预措施: [14C]XZP-3287 (Drug)
结局指标
主要结局
PK data for 14C-XZP-3287: Cmax
时间窗: up to 15 days
Maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity
PK data for 14C-XZP-3287: AUClast
时间窗: up to 15 days
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration for XZP-3287 in plasma and whole blood total radioactivity
PK data for 14C-XZP-3287: AUCinf
时间窗: up to 15 days
Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma and whole blood total radioactivity
PK data for 14C-XZP-3287: Tmax
时间窗: up to 15 days
Time of maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity
Quantitative analysis of cumulative excretion and excretion rate in excreta (urine and faeces)
时间窗: up to 15 days
Quantitative analysis of total radioactivity in excreta after oral \[14C\]XZP-3287 in healthy subjects, obtaining body material balance data and main excretion pathways
次要结局
- Tmax of XZP-3287 in plasma(up to 15 days)
- Cmax of XZP-3287 in plasma(up to 15 days)
- AUClast of XZP-3287 in plasma(up to 15 days)
- AUCinf of XZP-3287 in plasma(up to 15 days)
- To evaluate the safety of [14C] XZP-3287(up to 29 days)