ISRCTN14984258进行中（未招募）1 期
A single-center, single-sequence, open-label, two-period study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of the combination of multiple doses of ralmitaront with a single dose of risperidone in healthy subjects
Roche (Switzerland)0 个研究点目标入组 20 人开始时间: 2021年11月1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
- 20
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. A body mass index (BMI) between 18–30 kg/m², inclusive, at screening
- •2. Fluent in English
排除标准
- •1. History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, or cancer
- •2. Disorders of the CNS that are clinically significant as determined by the Investigator, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson’s, parkinsonism, and seizures
- •3. Elevated risk of clinically significant suicidal ideation and/or behavior within 2 years prior to screening as determined by the C-SSRS
- •4. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs. Uncomplicated appendectomy and cholecystectomy are acceptable
- •5. A history of clinically significant hypersensitivity (e.g. drugs, excipients) or allergic reactions
- •6. Hypersensitivity to risperidone or paliperidone, as stated in the prescribing information for risperidone
- •7. In the opinion of the Investigator, any major illness within 1 month before the screening examination, or any febrile illness within 1 week prior to screening and up to first study treatment administration
- •8. Use of prohibited medications (vaccines, over-the-counter [OTC] or prescription medication including herbal medications) taken within 14 days (or 5 times the elimination half-life of the medication, whichever is longer) prior to dosing, with the exception of acetaminophen up to 2 g per day, which is allowed up to 48 hours before dosing, and stable hormonal replacement or contraception therapy; COVID vaccine must be at least 21 days before dosing
- •9. Use of any drug or herbal inducers of CYP3A, CYP2C19, CYP2D6, or Pgp within 28 days prior to dosing
- •10. Participants likely to need concomitant medication during the study period (including for dental conditions)
- •11. Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drug of abuse in the last 5 years
- •12. Positive alcohol breath test or urine drug screen at screening or admission to the study site
- •13. Smokers who regularly smoke more than 5 cigarettes daily or equivalent and are unable or unwilling not to smoke during the confinement in CRU
- •14. Positive test result for human immunodeficiency virus (HIV) 1 and HIV 2, hepatitis C virus (HCV) antibody, or hepatitis B surface antigen (HBsAg)
- •15. Dietary restrictions that would prohibit the consumption of standardized meals
- •16. Participants under judicial supervision, guardianship, or curatorship
- •17. Women who are lactating
- •18. History of clinically significant back pain, back pathology, and/or back injury (e.g., degenerative disease, spinal deformity, spinal surgery, lumbar radiculopathy, chronic/recurrent headaches, intracranial tumors, and/or increase intracranial pressure) that may predispose to complications from, or technical difficulty with, a lumbar puncture
- •19. Criteria that would preclude a lumbar puncture, such as a local infection at the site of the lumbar puncture; clinically significant coagulation parameter abnormalities, thrombocytopenia, or treatment with an anticoagulant or with antiplatelet agents with
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