Early Phase 1
N=38
Quercetin PK/PD Study in Healthy Adults and Patients With Hypercoagulable States
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01722669 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: AUC — 4.78; 15.00; 5.41; 16.34 uM hr/L
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- isoquercetin or quercetin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC |
4.78; 15.00; 5.41; 16.34; 40.3 | — |
| SECONDARY Reductase Activity of PDI Using Dieosin Glutathione Disulfide |
31.9; 63.2; 16; 8.3; 38 | — |
| SECONDARY Platelet-induced Thrombin Generation (U/mL) |
0.30; 1.40 | — |
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
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:
- Estimated GFR >35 (formula),
- Platelet count >65 K/uL,
- Hemoglobin >10.5 grams/dL
- Total bilirubin 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
Data sourced from ClinicalTrials.gov (NCT01722669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.