Clinical trial NCT04421716: Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid
Official title: Phase I Clinical Trial Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Bioavailability of Phytonutrients
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number, frequency, duration, and relation of toxicity events
timeFrame: Baseline to 2 weeks
measure: Peak serum concentration
timeFrame: Baseline to 2 weeks
measure: Time to reach peak serum concentration
timeFrame: Baseline to 2 weeks
measure: Half-life
timeFrame: Baseline to 2 weeks
Secondary outcomes:
measure: Microbiome Alpha Diversity
timeFrame: Baseline to 2 weeks
measure: Microbiome Beta Diversity
timeFrame: Baseline to 2 weeks
measure: Metabolite Panels
timeFrame: Baseline to 2 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Michael A Liss, MD
role: PRINCIPAL_INVESTIGATOR
References: