NL-OMON50849已完成不适用
A single-center, open-label study to investigate the mass balance, excretion pathways, and metabolites after a single oral dose of 500 mg, 3.7 MBq, [14C]BTZ-043 in healthy male volunteers - Mass balance, excretion pathways, and metabolites of 14C-labeled BTZ-043
niversity Hospital LMU Klinikum0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Sex : male
- •2. Age : 18 years to 55 years, inclusive, at screening.
- •3. Body mass index (BMI) : 18.0 to 29.0 kg/m2, inclusive, at screening.
- •4. Weight : 55 to 90 kg, inclusive, at screening.
- •5. Status : healthy subjects.
- •6. Male subjects, if not surgically sterilized, must agree to use adequate
- •contraception and not donate sperm from admission to the clinical research
- •center until 90 days after the follow-up visit. Adequate contraception for the
- •male subject (and his female partner, if she is of childbearing potential) is
- •defined as using hormonal contraceptives or an intrauterine device combined
- •with at least 1 of the following forms of contraception: a diaphragm, a
- •cervical cap, or a condom. Total abstinence, in accordance with the lifestyle
- •of the subject, is also acceptable.
- •7. All prescribed medication must have been stopped at least 30 days prior to
- •admission to the clinical research center.
- •8. All over-the-counter medications, vitamin preparations (especially vitamin
- •C), other food supplements, and herbal medications (eg, St. John*s wort) must
- •have been stopped at least 14 days prior to admission to the clinical research
- •center. An exception is made for paracetamol, which is allowed up to 48 hours
- •prior to study drug administration.
- •9. No vaccination within 14 days prior to study drug administration.
- •10. Ability and willingness to abstain from alcohol from 48 hours (2 days)
- •prior to screening and admission to the clinical research center.
- •11. Ability and willingness to abstain from methylxanthine-containing beverages
- •or food (coffee, tea, cola, chocolate, and energy drinks), grapefruit (juice),
- •corn (whole corn kernels and popcorn), cruciferous vegetables, and bitter
- •oranges from 48 hours (2 days) prior to admission to the clinical research
- •12. Good physical and mental health on the basis of medical history, physical
- •examination, clinical laboratory, ECG, and vital signs, as judged by the
- •Investigator.
- •13. Willing and able to sign the ICF.
排除标准
- •1. Participation in another study with a radiation burden of >0.1 mSv and <=1
- •mSv in the period of 1 year prior to screening; a radiation burden of >1.1
- •mSv and <=2 mSv in the period of 2 years prior to screening; a radiation burden
- •of >2.1 mSv and <=3 mSv in the period of 3 years prior to screening, etc.
- •2. Exposure to radiation for diagnostic reasons (except dental X-rays and plain
- •X-rays of thorax and bony skeleton [excluding spinal column]), or during work
- •within 1 year prior to drug administration.
- •3. Irregular defecation pattern (less than once per day on average).
- •4. Employee of PRA, Nuvisan, or the Sponsor.
- •5. History of relevant drug and/or food allergies.
- •6. Using tobacco products within 60 days prior to drug administration.
- •7. History of alcohol abuse or drug addiction (including soft drugs like
- •cannabis products).
- •8. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
- •[including ecstasy], cannabinoids, barbiturates, benzodiazepines,
- •gamma-hydroxybutyric acid, tricyclic antidepressants, and alcohol) at screening
- •or admission to the clinical research center.
- •9. Average intake of more than 24 grams of alcohol per day.
- •10. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus
- •(HCV) antibodies, or HIV 1 and 2 antibodies.
- •11. Participation in a drug study within 30 days prior to drug administration
- •in the current study. Participation in more than 4 drug studies in the 12
- •months prior to drug administration in the current study.
- •12. Donation or loss of more than 450 mL of blood within 60 days prior to drug
- •administration. Donation or loss of more than 1.5 liters of blood in the 10
- •months prior to drug administration in the current study.
- •13. Significant and/or acute illness within 5 days prior to drug administration
- •that may impact safety assessments, in the opinion of the Investigator.
- •14. Unwillingness to consume the Food and Drug Administration (FDA)-recommended
- •high-fat breakfast.
- •15. Unsuitable veins for infusion or blood sampling.
- •16. Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1.
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