Angelica Herbal Supplement AGN-CognI.Q Acute Dose Safety and Pharmacokinetics (PK) Dose-Response in Prostate Cancer Patients (PK Dose Trial)
Objective
The primary objective is to estimate the maximum tolerated dose of AGN-CognI.Q. Subjects (total sample size n = 12 evaluable subjects), each for 4 ascending AGN-CognI.Q dose levels in the form of AGN-CognI.Q capsules (up to 10 capsules per dose), for single-dose safety metrics with a 1-week washout between doses.
The secondary objectives are several fold: To determine dose-response of PK metrics (especially uptake and exposure) for AGN pyranocoumarin compounds to AGN-CognI.Q supplement. The data will inform whether a metabolism capacity ceiling exists for parent compounds decursin and decursinol angelate (D, DA) and their metabolite decursinol (DOH). To determine any food effect on PK metrics at the respective maximally tolerated dose (MTD) of AGN CognI.Q in each subject to optimize herbal supplement and food schedule. To genotype CYP 2C19 and 3A4 metabolizer status and explore relationship to PK metrics and safety metrics. To explore responses of immunology tests as PD biomarkers. To monitor body temperature during
