NCT04421716

Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioavailability of Phytonutrients

Interventions

Type	Name	Description
DRUG	Ursolic Acid	Ursolic Acid 150mg
DRUG	Curcumin	Curcumin 600mg

Timeline

• Start date: 2020-10-20
• Primary completion: 2020-11-30
• Completion: 2021-04-16
• First posted: 2020-06-09
• Last updated: 2021-05-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study