Clinical trial NCT03554096: Brain Penetrance of 2-HOBA in Humans
Official title: Brain Penetrance of 2-Hydroxybenzylamine in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: Multiple Dosage
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University
name: National Institute on Aging (NIA)
First posted: 2018-06-12
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Brain Penetrance
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Metabolic Technologies Inc.
name: John A Rathmacher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pitchford LM, Driver PM, Fuller JC Jr, Akers WS, Abumrad NN, Amarnath V, Milne GL, Chen SC, Ye F, Roberts LJ 2nd, Shoemaker MB, Oates JA, Rathmacher JA, Boutaud O. Safety, tolerability, and pharmacokinetics of repeated oral doses of 2-hydroxybenzylamine acetate in healthy volunteers: a double-blind, randomized, placebo-controlled clinical trial. BMC Pharmacol Toxicol. 2020 Jan 6;21(1):3. doi: 10.1186/s40360-020-0382-y.