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AGN-CognI.Q Acute Dose Safety and Pharmacokinetics Dose-Response in Prostate Cancer Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

AGN-CognI.Q Acute Dose Safety and Pharmacokinetics Dose-Response in Prostate Cancer Patients

Angelica Herbal Supplement AGN-CognI.Q Acute Dose Safety and Pharmacokinetics (PK) Dose-Response in Prostate Cancer Patients (PK Dose Trial)

NCT05375539•Milton S. Hershey Medical Center

View on ClinicalTrials.gov

Summary

This study is to obtain acute dose safety and pharmacokinetics/pharmacodynamics (PK/PD) data in a dose-response trial in prostate cancer patients.

Detailed Description

The long-term goal of the study is to conduct human clinical trials to test Angelica gigas Nakai (AGN) root alcoholic extract herbal supplement product (AGN-CognI.Q, or CognI.QTM, made with INM®176 proprietary ingredient, Quality of Life Laboratories, Purchase, NY) as a safe and potential efficacious modality for prostate cancer interception akin to secondary prevention to delay hormonal therapy or avoid it entirely after patients have developed recurrent disease following their standard of care (SOC) surgery and radiation curative treatment. The acute dose safety and pharmacokinetics (PK) and pharmacodynamics (PD) information in the target patient population from the current proposed acute PK dose-response trial will inform the optimal design and execution of the longer-term safety and efficacy (phase I/II) trials.

Eligibility

Age

40 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Willingness and ability to give informed consent.
•2. Agree to comply with all study procedures and attend all study visits to the best of their ability.
•3. Male with age \>=40 years.
•1. Patients treated forprostate cancer and no detectable disease on imaging and clinical determination are eligible for enrollment, regardless of risk category.
•2. Patients in the low-risk and favorable intermediate-risk groups who are not currently receiving any treatment or have declined any treatment.
•5. Not on concurrent androgen deprivation therapy.
•6. ECOG performance status 0-2.
•7. Life expectancy of greater than 12 months.
•8. Subjects must have normal liver and kidney function as defined below:
•* a) total bilirubin within normal institutional limits,
+6 more criteria

Exclusion Criteria

•1. Subjects with distant metastatic cancer. Node positive prostate cancer patients are allowed after completion of treatment.
•2. Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy (checkpoint inhibitor).
•3. Subjects who are receiving any other investigational agents.
•4. Uncontrolled intercurrent illness that would limit compliance with study requirements.
•5. All vulnerable patient populations.
•6. History of New York Heart Association Class III or IV heart failure, history of a myocardial infarction within 6 months, any uncontrolled cardiac arrhythmia, or any other cardiac related problem that would be considered a contraindication for participation in the opinion of the treating physician.
•7. Use of androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens.
•8. Subjects who are taking Warfarin/Coumadin.

Locations (1)

Penn State Cancer Institute

Hershey, Pennsylvania, United States

Key Dates

Start Date

May 2, 2023

Primary Completion Date

February 15, 2025

Completion Date

February 15, 2025

Last Updated

September 10, 2025

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

AGN-CognI.Q

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AGN-CognI.Q Acute Dose Safety and Pharmacokinetics Dose-Response in Prostate Cancer Patients

Inclusion Criteria

Exclusion Criteria

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