ISRCTN84512888进行中（未招募）1 期
Safety, tolerability, pharmacokinetic and pharmacodynamic effects of single and multiple escalating doses ofODM-111 and effect of food on the pharmacokinetics of ODM-111.
Orion Corporation (Finland)0 个研究点目标入组 148 人开始时间: 2022年10月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
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
- All
入选标准
- •1. Written informed consent (IC) obtained
- •2. Good general health ascertained by detailed medical history and laboratory and physical examinations.
- •3. Males and females between 18 and 55 years (inclusive).
- •4. Body mass index (BMI) between 18-32 kg/m² (inclusive).
- •5. Weight 50-120 kg (inclusive).
- •6. Female participants with fertile male partner, and male participants with female partners of child-bearing potential, must adhere to a highly effective form of contraception (e.g. combined or progestogen only hormonal contraceptives associated with inhibition of ovulation, intrauterine devices or intrauterine hormone-releasing system), if sexually active and not permanently sterilised, for females from 4 weeks before the first study treatment administration, and for males from admission to study centre until 3 months after the end-of-study visit. Additionally, women who are postmenopausal (1 year since last menstrual cycle) are considered not to be reproductive and can be included. For male subjects, sperm donation is not allowed until 3 months after the end-of-study visit.
排除标准
- •1. A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions or communicate well with the investigator
- •2. Veins unsuitable for repeated venipuncture or for cannulation.
- •3. Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, immunologic, dermatologic, metabolic-endocrine, neurological, urogenital, psychiatric and/or other major disease as judged by the investigator. Any surgical or medical condition (including cholecystectomy) which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
- •4. Part I and Part III: Any current, clinically significant, known medical condition that would affect sensitivity to cold(such as atherosclerosis, Raynaud’s disease, urticaria, hypothyroidism) or pain
- •5. Part I: Intolerance of PainCart tests or tolerance at > 80% of maximum input intensity for any pain test for cold.
- •6. Part III: Intolerance of PainCart tests or tolerance at > 80% of maximum input intensity for any pain test for cold, pressure and electrical tests at the screening visit
- •7. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies(non-active hay fever is acceptable).
- •8. Intake of any medication that could affect the outcome of the study, as judged by the investigator, within 2 weeks before the first study treatment administration (1 month for enzyme inducing drugs like rifampicin orcarbamazepin), 4 weeks for live vaccines and 2 weeks for other vaccines including COVID-19 vaccines.
- •9. A history of alcoholism or current excess alcohol intake (including regular consumption of more than 2 units daily on average [1 unit = approximately 250 ml of beer, 100 ml of wine, or 35 m of spirits]); inability to refrain from the intake of alcohol from 48 h before the first study treatment administration and during the stay at the study centre.
- •10. Use of nicotine-containing products within 3 months before screening.
- •11. Inability to refrain from using nicotine-containing products during the stay at the study centre.
- •12. History of drug abuse within 2 years or positive drug screen at screening.
- •13. Inability to refrain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) before the admission and during the stay at the study centre.
- •14. Blood donation or loss of significant amount of blood (= 500 ml) within 3 months before the admission to study centre.
- •15. Abnormal 12-lead ECG finding of clinical relevance at the screening visit, (after 5 min rest in supine position, confirmed by a repeat measurement) for example:
- •15.1. QT c (calculated through the Fridericia’s formula) > 450 msec for male and > 470 msec for female subjects (If QTcinterval measured by the ECG machine algorithm is > 450/470 ms, 2 additional recordings will be done and mean QTcF value used to determine eligibility)
- •15.2. PR < 120 msec or > 200 msec
- •15.3. QRS < 70 msec or > 120 msec
- •15.4. 2° or 3° AV block
- •15.5. ventricular tachycardia
- •16. HR < 45 bpm or > 100
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