Healthy Adults Clinical Trial
Official title:
Brain Penetrance of 2-Hydroxybenzylamine in Humans
The purpose of this study is to confirm that 2-HOBA crosses the blood brain barrier and to compare blood and cerebrospinal fluid levels of 2-HOBA after a single oral dose.
Consenting volunteers between 40 and 70 years old with no morbidity, including males, and
females who are not pregnant will be recruited for the study. Three volunteers will be
enrolled with a reasonable sampling of ethnicities from the Nashville area, and an effort
will be made to recruit males and females. The study will be conducted by the Vanderbilt
Clinical Research Center (CRC).
Briefly, the three volunteers will be studied at a single dose level. Baseline assessments
will be performed, and then each volunteer will be given a single oral dose (550 mg) of
2-HOBA. Ninety minutes after the dose, a lumbar puncture will be performed to obtain
cerebrospinal fluid and a blood sample will be collected. 2-HOBA levels will be measured in
cerebrospinal fluid and blood samples from this timepoint to assess the ability or orally
ingested 2-HOBA to cross the blood brain barrier.
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