Pharmacokinetic and Pharmacodynamic Study of Oral Quercetin and Isoquercetin in Healthy Adults and Patients With Hypercoagulable States. (PK/PD)

NCT01722669 EARLY_PHASE1 COMPLETED Results posted

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

Details

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	EARLY_PHASE1
Status	COMPLETED
Enrolment	38
Start date	2012-05
Completion	2019-12

Conditions

• Healthy

Interventions

• isoquercetin or quercetin

Primary outcomes

• 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)

Countries

United States