Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

NCT04421716 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: HSC20190940H
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bioavailability of Phytonutrients

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Microbiome Alpha Diversity

  Baseline to 2 weeks

• Microbiome Beta Diversity

  Baseline to 2 weeks

• Metabolite Panels

  Baseline to 2 weeks

Study Arms (3)

Ursolic Acid

EXPERIMENTAL

Administration of Ursolic Acid twice a day for 2 weeks

Drug: Ursolic Acid

Curcumin

EXPERIMENTAL

Administration of Curcumin twice a day for 2 weeks

Drug: Curcumin

Ursolic Acid and Curcumin

EXPERIMENTAL

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; Drug: Curcumin

Interventions

Ursolic Acid DRUG

Ursolic Acid 150mg

Ursolic Acid; Ursolic Acid and Curcumin

Curcumin DRUG

Curcumin 600mg

Curcumin; Ursolic Acid and Curcumin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Ursolic Acid; Curcumin

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals; Sapogenins; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Michael A Liss, MD

  University of Texas Health at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort 1 and 2 will receive either UA or CURC and Cohort 3 will receive a combination of UA and CURC. Subjects initially enrolled in Cohorts 1 and 2 may have the option to continue in Cohort 3.

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 9, 2020
• Study Start: October 20, 2020
• Primary Completion: November 30, 2020
• Study Completion: April 16, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: De-identified data will be available upon request following study completion for approx. 1 year.
• Access Criteria: Access available upon request.

Locations

US (1)