Quercetin PK/PD Study in Healthy Adults and Patients With Hypercoagulable States

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to evaluate how much quercetin or isoquercetin is absorbed after a single dose and evaluate for pharmacokinetic inhibition of protein disulfide isomerase. Pharmacodynamic studies will also be performed in an additional cohort of 10 patients with evidence of antiphospholipid antibodies

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Antibodies; Antibodies, Antiphospholipid; Quercetin

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