Explorative, randomized, double-blind, placebo-controlled, 3-way cross-over study to assess the effects of oral cannabidiol 30 and 700 mg in healthy male subjects on CNS and cortical excitability using the NeuroCart test battery and TMS.

Centre for Human Drug Research0 个研究点目标入组 24 人开始时间: 2023年10月9日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Centre for Human Drug Research
入组人数: 24

研究概览入排标准研究者记录与标识符相似试验

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（—）
性别: Male

入选标准

•Signed informed consent prior to any study-mandated procedure., Healthy male subjects, 18 up and to 55 years of age, inclusive at screening., Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg., All subjects must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment., Has the ability to communicate well with the investigator in the Dutch language and willing to comply with the study restrictions.

排除标准

•Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the investigator to have no clinical relevance., Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects., History or presence of conditions which, in the judgment of the investigator, might increase the risk of performing TMS, including but not limited to epilepsy or febrile seizures, intracranial mass lesion, hydrocephalus, clinically significant head injury or trauma, metal objects in the brain or skull, cochlear implant or a deep brain stimulation device., Any condition that could interfere with the quality or ability to perform TMS, such as an abnormal sleeping pattern (e.g., working night shifts), dreadlocks or hairpieces that cannot be removed or a rMT of more than 75% of the maximum stimulator output as measured using TMS-EMG during screening., Female subjects are excluded because the menstrual cycle can influence TMS-EMG and TMS-EEG measures.

研究者

发起方

Centre for Human Drug Research

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