Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

Phase I Clinical Trial Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

The primary objective of this research is to investigate the bioavailability of curcumin (CURC) and ursolic acid (UA) in a phase I clinical trial in healthy men and obtain biological material for bioavailability analysis.

Study Overview

• Status: Completed
• Conditions: Bioavailability of Phytonutrients
• Intervention / Treatment: Drug: Ursolic Acid; Drug: Curcumin

Detailed Description

Once a subject is consented and assigned to a cohort, the subject may undergo a digital rectal exam (DRE) and rectal swab fecal collection and provide research blood (including CBC and CMP safety labs) and urine. Medical history data will be collected and reviewed. The PI and/or study staff will provide supplement administration and supplement diary education prior to the subject starting their dose of UA, CURC, or UA and CURC combination. Pharmacokinetic (PK) and pharmacodynamic (PD) assessments will be collected at pre-dose and 6 and 24 hours after the first dose. Urine will also be collected at pre dose and 24 hours post dose. The dosing period will be for a total of 2 weeks (± 3 days). On the last day of dosing, subjects will attend a research only visit at which the subject may undergo a digital rectal exam (DRE) and rectal swab fecal collection and provide research blood and urine. At this time, the subject's supplement diary will be reviewed and a safety/AE assessment will be completed. In addition, research CBC and CMP safety labs will be collected. If a subject initially enrolled in Cohort 1 or 2 decides to continue in Cohort 3, the subject will undergo a wash out period of at least 4 weeks and repeat all study procedures for Cohort 3.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Be able to give informed consent
• Be men age 18 or older
• Able to stop supplements

Exclusion Criteria:

• Unable to give informed consent
• Age < 18
• Woman
• Prisoners
• Diagnosed cancer
• Unable to swallow pills
• Unable to stop supplements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ursolic Acid; Administration of Ursolic Acid twice a day for 2 weeks	Drug: Ursolic Acid; Ursolic Acid 150mg
Experimental: Curcumin; Administration of Curcumin twice a day for 2 weeks	Drug: Curcumin; Curcumin 600mg
Experimental: Ursolic Acid and Curcumin; Administration of Ursolic Acid and Curcumin. If subjects from Cohort 1 or 2 wish to continue in the study, they will undergo a washout period of at least 4 weeks before participating in Cohort 3	Drug: Ursolic Acid; Ursolic Acid 150mg; Drug: Curcumin; Curcumin 600mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number, frequency, duration, and relation of toxicity events	Safety will be compared to evaluate the number, frequency, duration, and relation of toxicity events to CURC and UA, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03.	Baseline to 2 weeks
Peak serum concentration	Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed.	Baseline to 2 weeks
Time to reach peak serum concentration	The pharmacokinetic parameter, the area under the curve (Tmax) representing the time it takes to reach Cmax of ursolic acid, curcumin, and their metabolites will be graphed.	Baseline to 2 weeks
Half-life	The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.	Baseline to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome Alpha Diversity	Number of bacteria collected from rectal culture sample will be assessed before and after each exposure	Baseline to 2 weeks
Microbiome Beta Diversity	Proportions of bacteria collected from rectal culture sample will be assessed before and after each exposure	Baseline to 2 weeks
Metabolite Panels	Metabolite panels will be placed into quartiles and compared to predicted function from the bioinformatics tool Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) software.	Baseline to 2 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Michael A Liss, MD, University of Texas Health at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): April 16, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Curcumin; Ursolic acid
• Other Study ID Numbers: HSC20190940H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data will be available upon request.
• IPD Sharing Time Frame: De-identified data will be available upon request following study completion for approx. 1 year.
• IPD Sharing Access Criteria: Access available upon request.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No