NCT01722669

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

Pharmacokinetic and Pharmacodynamic Study of Oral Quercetin and Isoquercetin in Healthy Adults and Patients With Hypercoagulable States.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	isoquercetin or quercetin	Single dose PK/PD study

Timeline

• Start date: 2012-05-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2012-11-07
• Last updated: 2020-10-12
• Results posted: 2020-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study