ISRCTN12728443进行中（未招募）1 期
Pharmacokinetics, absolute bioavailability and excretion balance after a single oral dose and IV microtracer dose of [14C]ODM-111; an open-label, non-randomised, single centre study in healthy male subjects
Orion Corporation (Finland)0 个研究点目标入组 8 人开始时间: 2024年7月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8
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
- 性别
- Male
入选标准
- •1. Must provide written informed consent.
- •2. Must be willing and able to communicate and participate in the whole study.
- •3. Aged 30 to 65 years inclusive at the time of signing informed consent.
- •4. Must agree to and adhere to the contraception requirements defined in the clinical protocol.
- •5. Males who are healthy as determined by medical evaluation including medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (haematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
- •6. Body mass index (BMI) of 18.5 to 32.0 kg/m2 as measured at screening.
- •7. Weight 55 to 100 kg at screening.
- •8. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day).
排除标准
- •1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
- •2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
- •3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator.
- •4. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening.
- •5. Any clinically significant physical examination finding, as judged by the investigator.
- •6. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed.
- •7. Subjects who exhibit any first, second or third degree atrioventricular (AV) block at screening.
- •8. Subjects who have systolic BP <90 mmHg or >140 mmHg or diastolic BP <45 mmHg or >90 mmHg after 5 min in a supine position at screening.
- •9. Abnormal 12-lead ECG finding of clinical relevance at the screening visit or at pre-dose, (after 5 min rest in supine position), confirmed by a repeat measurement.
- •10. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results.
- •11. Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009) equation.
- •12. ALT or aspartate aminotransferase greater than the upper limit of normal (ULN) at screening.
- •13. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer.
- •14. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.
- •15. Subjects who have been administered IMP in an ADME study in the last 12 months.
- •16. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood.
- •17. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study. COVID-19 vaccines are accepted concomitant medications.
- •18. Subjects who have had a COVID 19 vaccine 72 h before admission.
- •19. History of any drug or alcohol abuse in the past 2 years.
- •20. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).
- •21. A confirmed positive alcohol breath test at screening or admission.
- •22. Current smokers and those who have smoked within the last 12 mon
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