Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT06369350
Eligibility Criteria:
Inclusion Criteria:
* Are males and females at least 21- 70 years of age (inclusive)
* Capable of giving informed consent
* Are of any race or ethnicity
* Can communicate in English
* Females may be on oral contraceptives but will be excluded if they are pregnant or lactating
* Healthy Status as defined by the absence of evidence of any active or chronic disease as determined by the following:
* a detailed medical history
* complete physical examination (including vital signs)
* a blood pressure that is within a safe range (\<150/100mmHg)
Exclusion Criteria:
* \< 21 years of age or \> 70 years of age
* Pregnant or nursing woman
* Prisoners or institutionalized individuals unable to consent
* Decisional impairment
* Not able to communicate in English.
* Current smoker
* Have any clinically relevant history or the presence of metabolic (e.g., diabetes), respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or other disease or diseases that, in the opinion of the research team, exclude the subject from participation.
* Presenting with a resting blood pressure of 150/100 or higher
* Taking any medications that affect vascular control or autonomic function (e.g. beta blockers, ACE inhibitors, calcium channel blockers, etc.)
* Taking a multivitamin with B6, a B-complex vitamin, or vitamin B-6 at baseline, with a history of Parkinson's disease, and taking levodopa
* Known allergy or hypersensitivity to Vitamin B6
* Opioid Use Disorder or on opioid therapy
* Subject has a recent drug or alcohol abuse history (less than 6 months) or is currently using or abusing excessive alcohol or drugs. Excessive alcohol will be defined as greater than 14 drinks per week. Use of recreational drugs in the past 6 months is also an exclusion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT06369350
Study Brief:
Protocol Section:
NCT06369350