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

Completed · Early Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01722669

Run by

Beth Israel Deaconess Medical Center

People needed

38

Starts

2012-05-01

Expected to finish

2019-12-01

Last updated by the study team

2020-10-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• Estimated GFR >35 (formula),
• Platelet count >65 K/uL,
• Hemoglobin >10.5 grams/dL
• 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)

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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