A prospective, methodology study to identify potential biomarkers of myelin dynamics in CSF using metabolic labeling with stable isotopes in healthy volunteers - Biomarkers of myelin dynamics in CSF

Centre for Human Drug Research0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年8月12日

适应症

试验速览

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•- Signed informed consent prior to any study-mandated procedure;
•- Males or females, aged 18-70 years;
•- BMI between: 18-30 kg/m2, minimal weight 50 kg
•- Ability to communicate well with the investigator in the Dutch language.
•- Ability to easily visit CHDR in Leiden oncea week
•- Expected compliance to the protocol with respect to drinking D2O 2 times every day for 70 days

•- 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 case of uncertain or questionable results, tests performed during screening may be repeated before the first occasion to confirm eligibility or judged to be clinically irrelevant.
•- Subject is pregnant or breastfeeding.
•- Any contraindication for a lumbar puncture.
•- Recent (within 60 days) or current use of medications.
•- Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
•- Positive test for drugs of abuse at screening or pre-dose.
•- Alcohol is prohibited from 24 hours before screening and the first visit.
•- History or symptoms of any significant disease including (but not limited to) neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
•- Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
•- Donation of blood over 500 mL within 3 months prior to screening.
•- Unwillingness or inability to comply with the study protocol for any other reason.

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