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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT05973656
Eligibility Criteria:
Inclusion Criteria:
* 21-45 years of age for alcohol drinkers
* Occasionally consume alcohol
* At least 1 drink per month for healthy volunteers
* At least 1 drink in the last 3 months for Fanconi anemia patients
* Meets one of the three criteria
* Healthy volunteer - ALDH2\*1/1\* homozygotes-not of Eastern Asian decent;
* Healthy volunteer - ALDH2\*1/2\* heterozygotes-of Eastern Asian decent and experience flushing when drinking
* Individual's with Fanconi anemia (FA).
* 18-45 years of age for non-drinkers
* Never consume alcohol/not had alcohol in the last 6 months
* Healthy volunteers.
* Non-smoker (smoked \< 100 cigarettes in a lifetime)
Exclusion Criteria:
* Pregnant or nursing
* Taking any medication or drug that might affect alcohol use and absorption or that might be affected by alcohol consumption
* Healthy volunteers who have taken any antibiotics in the last 3 months
* Currently consuming more than 21 drinks per week
* Have any history of alcohol or drug related problems
* Current or former tobacco/nicotine product(s) user
* Any regular use of tobacco/nicotine products or marijuana in the last year (cigarettes, e-cigarettes, cigars, pipes, smokeless tobacco)
* "Trying" or limited use of any nicotine products or marijuana in the last 1 month
* Active infection (influenza, cold, COVID, respiratory / sinus infection) - admission in the study will be delayed pending improved health
* Non-FA volunteers who have an unstable medical condition or condition that could be affected by alcohol consumption (insulin-dependent diabetes, ulcers, heart issues)
* Experience severe adverse events (nausea, blacking out) when consuming even low doses of alcohol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05973656
Study Brief:
Protocol Section:
NCT05973656