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

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: isoquercetin or quercetin

• Registration Number: NCT01722669
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief 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

Detailed Description

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-07
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Results First Submitted: 2020-04-06
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-09
• Last Update Submitted: 2020-10-09
• Results First Posted: 2020-10-12
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isoquercetin	isoquercetin or quercetin	Single dose of isoquercetin with or without ascorbic acid
Quercetin	isoquercetin or quercetin	Single dose of quercetin with or without ascorbic acid

Primary Outcome Measures

Name	Time	Method
AUC	24 hours	AUC 0-24 hours of measured plasma quercetin aglycone for Arms A1, B1, A2, B2, C Collected at timepoints: baseline and 1, 2, 4, 6, 8, and 24 hours after dose. PK and PDI samples were not measured for Arm D (anti-phospholipid antibody cohort)

Secondary Outcome Measures

Name	Time	Method
Reductase Activity of PDI Using Dieosin Glutathione Disulfide	2 hours. Not measured in D	Measurement of protein disulfide inhibition in plasma using a fluorescent PDI substrate (dieosin glutathione disulfide)
Platelet-induced Thrombin Generation (U/mL)	4 hours	Thrombin induced thrombin generation measured in patient plasma

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States