2-HOBA: Initial Evaluation in Humans

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to evaluate the administration of single doses of 2-HOBA in humans, with an escalation of doses that begins with the calculated Maximum Recommended Starting Dose. This evaluation will assess tolerability to oral administration of 2-HOBA, obtain pharmacokinetic data, characterize the 2-HOBA metabolic pathways, and determine the relation of dose to prevention of formation of bi-functional electrophile adducts in blood. Characterization of the metabolic fate of 2-HOBA will be supported by investigations that evaluate metabolism in microsomes and cells.

Key facts

Study ID

NCT03176940

Run by

Metabolic Technologies Inc.

People needed

18

Starts

2017-08-02

Expected to finish

2018-04-30

Last updated by the study team

2018-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy individuals older than 18;
• Males and females who are not pregnant at the time of the study; and
• Not taking any medication 2 weeks prior to and during the study.

You may not qualify if…

• Inability to give informed consent;
• Diseases that could manifest symptoms or signs that would confound interpretation of the relation between drug action and potential adverse effects;
• Diseases that could manifest morbidity;
• Known cardiac disease, kidney disease, or hepatic dysfunction;
• The need to discontinue any drug that is administered as standard of care treatment; and
• Unwillingness or inability to use approved birth-control methods.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.