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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2019-12-31

Brief Summary

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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

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Detailed Description

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To compare the absorption and activity of quercetin or isoquercetin with or without ascorbic acid in healthy adults. Oral chews containing quercetin (500mg) or isoquercetin(500 mg total) with or without ascorbic acid will be given. Pharmacokinetic parameters (AUC, Cmax, Tmax, elimination half-life) will be determined over 24 hours (8 time points). Pharmacodynamic inhibition of protein disulfide isomerase activity will also be assessed.

In addition to healthy subjects, a cohort of 10 individuals with antiphospholipid antibodies will participate. These participants will receive isoquercetin 1000 mg and have pharmacodynamics studies performed at time 0 and 4 hours.

All study drugs will be provided by Quercegen Pharma.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Quercetin

Single dose of quercetin with or without ascorbic acid

Group Type EXPERIMENTAL

isoquercetin or quercetin

Intervention Type DRUG

Single dose PK/PD study

Isoquercetin

Single dose of isoquercetin with or without ascorbic acid

Group Type ACTIVE_COMPARATOR

isoquercetin or quercetin

Intervention Type DRUG

Single dose PK/PD study

Interventions

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isoquercetin or quercetin

Single dose PK/PD study

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes