Brain Penetrance of 2-HOBA in Humans

Completed · Not applicable

Conditions studied: Healthy Adults

In brief

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.

Key facts

Study ID

NCT03554096

Run by

Metabolic Technologies Inc.

People needed

3

Starts

2018-05-23

Expected to finish

2019-02-08

Last updated by the study team

2019-02-20

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy individuals between 40 and 70 years old;
• Men and women who are not pregnant at the time of study; and
• Not taking any medication 24 hours prior to and during the study.

You may not qualify if…

• Inability to give informed consent;
• Current use of anticoagulant medications, such as warfarin (Coumadin), dabigatran (Pradaxa), or rivaroxaban (Xarelto), due to high risk of bleeding complications. Volunteers taking aspirin or clopidogrel (Plavix), will not be excluded, but will be asked to get clearance from their prescribing physician before stopping the drug 24 hours prior to the procedure;
• Need to discontinue any drug that is administered as standard of care treatment;
• Unwillingness or inability to use approved birth-control methods (pre-menopausal women); and
• History of lumbar surgery, fibromyalgia, current lower back pain, or scoliosis.

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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