Angelica Herbal Supplement AGN-Cognl.Q Acute Dose Safety and Pharmacokinetics (PK) Dose-Response in Prostate Cancer Patients (PK Dose Trial)
The primary objective is to estimate the maximum tolerated dose of AGN-Cognl.Q. Subjects (total sample size n = 12 evaluable subjects), each for 4 ascending AGN-Cognl.Q dose levels in the form of AGN-Cognl.Q capsules (up to 10 capsules per dose), for single-dose safety metrics with a 1-week washout between doses.
Consented patients will be screened for physical exam and lab tests, and vital signs to establish eligibility (Visit 1, screening visit). The subjects will need to come into the research clinic in Hershey Medical Center on a weekly basis to take a single dose of AGN-CognI.Q by mouth in the morning for a series of blood draw over the span of the next 24 h to measure the amount of AGN Cognl.Q in their body. The total number of times the subjects will visit the clinic is 8 including a Screening visit (Visit 1) and an End of Treatment visit (Visit 8).
agree to comply with all study procedures and attend all study visits to the best of their ability
male with age >= 40 years
Histologically confirmed prostate cancer diagnosis in the past
Not on concurrent androgen deprivation therapy
Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy
Subjects who are receiving any other investigational agents
Uncontrolled intercurrent illness that would limit compliance with study requirements
Subjects currently taking herbal supplements containing AGN extract, including Cognl.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin