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

NCT05375539 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: PSCI-21-173R01CA260901
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Angelica gigas Nakai; INM 176; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Cardiac Safety Via Electrocardiography (EKG)

  Evaluation of cardiac rhythm and repolarization using 12-lead EKG to identify any treatment-emergent abnormalities. Unit of Measure: Number of participants with treatment-emergent EKG abnormalities.

  Baseline (pre-dose) and 5 hours post-dose on each dosing day and at 24 hours (Up to 5 weeks).

• Safety Blood Laboratory Tests

  Evaluation of hematological and metabolic safety via Complete Blood Count (CBC) with differential, Comprehensive Metabolic Panel (CMP), and coagulation tests (INR, PT, PTT) to identify any treatment-emergent abnormalities.

  24 hours post-dose and prior to each subsequent dose level (Up to 5 weeks).

Secondary Outcomes (5)

• Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH

  0 to 24 hours post-dose for each dosing visit (Up to 5 weeks)

• Plasma Concentration Versus Time Curve (AUC)

  0 to 24 hours post-dose for each dosing visit (Up to 5 weeks)

• Change From Baseline in NK, CD4+ T, and CD8+ T Cell Percentages at 24 Hours.

  Baseline (0 hours) and Day 2 (24 hours post-dose).

• Body Temperature Measurements From Baseline Through 24 Hours Post-dose

  Baseline (0 hours) and 24 hours post-dose.

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  From first dose of study drug to 4 weeks (± 7 days) following the last dose.

Study Arms (1)

AGN-Cogni.Q

EXPERIMENTAL

Dose level +1 (800 mg, 4 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +2 (1,200 mg, 6 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +3 (1,600 mg, 8 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after)

Drug: AGN-Cogni.Q

Interventions

AGN-Cogni.Q DRUG

Herbal dietary supplement products containing/based on AGN alcoholic extracts (including CognI.Q; Decursinol-50TM, GWB78®, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) are marketed in the US for memory enhancement, pain relief and for women's post-menopausal symptom management.

Also known as: INM®176

AGN-Cogni.Q

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness and ability to give informed consent.
• Agree to comply with all study procedures and attend all study visits to the best of their ability.
• Male with age \>=40 years.
• History of prostate cancer diagnosis. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded. Subjects are eligible if meet one or more of the below criteria:
• Patients treated forprostate cancer and no detectable disease on imaging and clinical determination are eligible for enrollment, regardless of risk category.
• Patients in the low-risk and favorable intermediate-risk groups who are not currently receiving any treatment or have declined any treatment.
• Not on concurrent androgen deprivation therapy.
• ECOG performance status 0-2.
• Life expectancy of greater than 12 months.
• Subjects must have normal liver and kidney function as defined below:
• a) total bilirubin within normal institutional limits,
• b) AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal,
• c) Creatinine within 1.5 ULN of institutional limits OR creatinine clearance \> 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
• d) Adequate bone marrow function (Hgb ≥ 9.0 g/dL, Platelets ≥ 100 x 109/L, absolute neutrophil count (ANC) of ≥ 1.5 x 109/L), except for subjects with a history of chronic benign neutropenia, where an ANC of ≥ 1.0 x 109/L are eligible.
• Subjects must agree to use two medically accepted method of contraception and must agree to continue use this method while on the trial and through at least one week after the last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) withdrawal, spermicides only, or lactational amenorrhea are not acceptable methods of contraception.

You may not qualify if:

• Subjects with distant metastatic cancer. Node positive prostate cancer patients are allowed after completion of treatment.
• Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy (checkpoint inhibitor).
• Subjects who are receiving any other investigational agents.
• Uncontrolled intercurrent illness that would limit compliance with study requirements.
• All vulnerable patient populations.
• 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.
• Use of androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens.
• Subjects who are taking Warfarin/Coumadin.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

The second participant of the trial experienced an herbal-drug adverse interaction at the first dose of AGN-Cogni.Q (800 mg) with warfarin (7.5 mg) anti-coagulant maintenance medication, leading to increased bleeding risk as measured by PT/INR (from 2 to 8). Persons taken warfarin blood thinner drug should not take AGN supplement to avoid this bleeding risk.

Results Point of Contact

• Title: Junxuan Lu, PhD, Bernard B. Brodie Professor of Pharmacology
• Organization: Pennsylvania State University

junxuanlu@pennstatehealth.psu.edu

7175318964

Study Officials

• Monika Joshi, MD

  Penn State Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: After the first subject is enrolled, a 14-day waiting period must occur between each subject before the next subject can be enrolled and dosed. If one subject develops a DLT at any dose level, that subject will cease treatment but will continue safety assessments follow-ups. If a second subject develops a DLT at the same dose level, the trial will be stopped and the dose level below will be the MTD. Any subjects who are at higher dose level at the time of 2nd DLT occurrence, will also stop with no further escalation. All subjects will start at the 800 mg dose (visit 2). Each subject will continue to the next week's dose until a DLT has been reached. However, if 2 DLTs occur at the starting 800 mg dose level, trial will be suspended.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 16, 2022
• Study Start: May 2, 2023
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after publication
• Access Criteria: Deidentified individual participant data will be available to qualified researchers upon reasonable request to the study investigators, following publication and in accordance with institutional and NIH data sharing policies.

Locations

US (1)