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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01722669
Eligibility Criteria:
Inclusion Criteria
* Subject is willing to participate and provide informed consent
* Subject is considered reliable and capable of adhering to the protocol per the judgment of the Investigator
* Subjects in group D must exhibit good organ reserves (within prior 4 weeks) defined as:
1. Estimated GFR \>35 (formula),
2. Platelet count \>65 K/uL,
3. Hemoglobin \>10.5 grams/dL
4. Total bilirubin \<2.0 mg/dL
* Minimum age 18 years old
* Body mass index (BMI) between 18 and 35 kg/m2
* For cohort D (antiphospholipid antibodies) a. Subjects in group D must have at least one positive antiphospholipid antibody within the last 8 weeks and/or previous confirmed antibodies (2 or more occasions at least 12 weeks apart) : i. Positive lupus anticoagulant ii. anticardiolipin antibody IgM or IgG (\>40U GPL) iii. anti-β2 Glycoprotein1 antibody titer (\>35 units)
Exclusion Criteria
* Pregnant. If female of child-bearing age, negative urinary pregnancy test prior to dosing of quercetin or isoquercetin
* No history of malabsorptive gastrointestinal disorder
* Currently taking aspirin, NSAIDS, warfarin, low-molecular weight heparin or other anticoagulants (such as direct thrombin inhibitors or factor X inhibitors)
a. Note: Study subjects taking aspirin or NSAIDS, if treating physician concurs, are permitted to enroll if plan to hold for aspirin 10 days or NSAIDS 24 hours prior to dosing of quercetin/isoquercetin
* Prescribed niacin for hyperlipidemia
* Known HIV
* History of sensitivity or intolerance to flavonoids, niacin or ascorbic acid
* May not have uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01722669
Study Brief:
Protocol Section:
NCT01722669